A Narrative Review of Patient-reported Outcomes in Overactive Bladder: What is the Way of the Future?

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].

3.1. Placebo and training effects in OAB trials

Clinical trials for the treatment of OAB have noted a significant response in patients treated with placebo [18]. According to Mangera et al [19], bladder diaries may influence treatment outcomes in randomized controlled trials (RCTs) of treatment with antimuscarinic agents because of the unique contribution bladder diaries have toward the placebo effect. One issue is experimental subordination, where a patient answers subjective questions in a way that is seen to please their physician [19]. Also, as OAB constitutes a complex of symptoms, behaviors, and behavior modifications, a bladder training effect is apparent when visual feedback of performance trains the patient to change their behavior [20]. This has been recognized in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB Diagnosis and Treatment Guidelines [21] that note that a self-monitoring effect may occur as a daily diary makes patients aware of their voiding habits. A placebo response is evident from this survey in clinical trials of OAB, as seen in Table 1.

3.2. Correlations between PRO measures and bladder diary endpoints

Significant correlations between widely-used PROMs and bladder diary endpoints exist within OAB literature. The OABSS, for example, consists of the sum score of four symptom items: daytime frequency, nighttime frequency, urgency, and UUI [11]. In the original validation, the actual number of daytime and nighttime urinations were gathered and urgency and UUI were assessed with a frequency scale. Each symptom score correlated positively with the OABSS (r_s = 0.10–0.78). In a comparison study of the OABSS to a 3-d bladder diary [22], statistically significant improvements in all OABSS and corresponding bladder diary variables (p < 0.001) were found with high correlations (r_s ≥ 0.5) between score changes in nighttime frequency and UUI. Consequently, the OABSS is an alternative to a diary for assessment in clinical practice. The OAB-q is a validated 33-item symptom bother and HRQoL questionnaire [12]. The coping and social interactions subscales significantly correlate with the number of urinations per day (r = –0.20 and –0.23 respectively, p = 0.02). The sleep subscale and number of urinations per night were highly correlated (r = –0.50, p < 0.0001). A validation study comparing the 1-wk and 4-wk versions of the OAB-q to a 3-d diary, found moderate to strong correlations between the OAB-q subscales and nearly all diary variables [23].

The Overactive Bladder Awareness Tool (OAB-V8) is a validated 8-item instrument [24]. In the validation of the OAB-V8, clinical variables of urgency, nocturia, and daytime frequency were collected with a bladder diary and compared with OAB-V8 scores; the OAB-V8 performed well with high sensitivity (0.96) and specificity (0.827).

The Questionnaire-Based Voiding Diary (QVD) is another validated instrument with a high correlation to a 48-h bladder diary [25] and [26]. The sensitivity, specificity, and positive likelihood ratio of the QVD for diagnosis of UUI were 0.82, 0.79, and 4.0, respectively. The authors conclude that the QVD is a useful alternative to the bladder diary. See Table 2 for a summary of correlations between PROMs and bladder diary endpoints.

3.3. Burden, over/underestimation, and lack of validation

Several publications highlight issues regarding the burden of, lack of compliance with, and overestimation of symptom frequency using bladder diaries. Diaries place a large inconvenience on patients [22] and [27]. In one study, compliance with diaries was found to be high in the office setting, yet 52% of patients demonstrated issues with adherence to instructions at home [28]. In another study, only 47% of women (p = 0.01) were found to accurately report daytime frequency using a diary [29]. Other studies of many patients overestimated or underreported nighttime frequency using a diary when compared with a medical chart [30] and [31].

Although bladder diaries are considered to be the gold standard for OAB diagnosis and remain useful in clinical practice and research, they lack validation and vary greatly in terms of content, format, and duration of recall period. In 2011, Bright et al [32] conducted a review of 81 studies using bladder diaries and concluded that, at that time, no validated urinary diary existed. See Table 3 for a summary of burden, over/underestimation, and lack of validation in bladder diaries.

3.4. Recall periods

In diagnosing OAB, patients’ completion of the diary for 2–3 d has been recommended [33], other recommendations in literature range from 24 h to 2 wk [9]. In clinical trials it is common to complete diaries for 3–7 d. In general, shorter recall periods are considered better than longer recall periods as rating variance increases the longer the delay there is between an event and the reporting of it [34]. However, researchers have found that 1-wk diaries are as reliable as 2-wk diaries and a comparison of a 5-d diary to a 24-h diary found the 24-h diary overestimated the maximum volume voided [35] and [36].

Recall periods in other chronic, symptomatic conditions were reviewed. In pain and fatigue assessments, when momentary reports were compared with recalled reports (over 1–28 d) substantial concordance was found between reports, suggesting that longer recall periods do not necessarily lead to substantially less accurate results [37]. Research in cancer pain confirms that 24-h recall and 7-d recall can be highly correlated [38]. Conversely, there is some evidence, in pain, that a 7-d window may more accurately characterize a patient's condition than the assessment of their current status [39]. See Table 3 for a summary of recall periods in bladder diaries.

3.5. Recommended endpoints in OAB

The International Consultation on Incontinence Research Society highlighted the need for a standardized measure in all outcome evaluations to increase comparability and standardize the assessment between different treatment evaluations in different populations [3]. The International Consultation on Incontinence Research Society recommends that a comprehensive evaluation should encompass satisfaction, symptoms, HRQoL, and adverse events as elements of a minimum in any outcome measurement. It is of note that OAB clinical trials have reported individual symptoms in isolation (eg, frequency) as primary outcomes; however, this approach may neither portray true therapeutic outcomes nor reflect what matters most to patients [2]. Instead, the use of composite endpoints may more accurately reflect the nature of OAB symptoms and correlate better with improved patient HRQoL, treatment satisfaction, and persistence; thereby harmonizing the reporting of trial data by removing confusion caused by individual symptom reporting.

3.6. Endpoints in similar syndrome-defined conditions

We also examined literature in relevant therapeutic areas and syndrome-defined chronic conditions (eg, restless legs syndrome [RLS]) that are patient identified and that have relied on diaries to gather symptom response. In interstitial cystitis/bladder pain syndrome where investigators historically have relied on diaries to assess treatment, our review reveals a change in interstitial cystitis/bladder pain syndrome endpoints. In a 2014 phase 3 RCT for the treatment of interstitial cystitis, investigators used the O’Leary-Sant questionnaire as primary outcome measures instead of a diary [40].

Benign prostatic hyperplasia (BPH) relies on PROMs as a primary endpoint. In a recent RCT to compare monotherapy versus combination therapy for OAB symptoms induced by BPH, the primary endpoint was a total change in OABSS score [41]. Secondary endpoints included the change in both OABSS and total International Prostate Symptom Score. A systematic review of solifenacin/tamsulosin in therapy for patients with BPH reveals widespread utilization of the International Prostate Symptom Score as a coprimary endpoint alongside diaries [42]. RCTs of treatments for RLS now routinely rely on the use of PROMs to document treatment efficacy, tolerability, symptom severity, and improvement. Allen et al [43] compared treatments for RLS using PROMs instead of traditional diary outcomes. Similarly, other pharmacological trials have defined RLS treatment response in terms of PROMs endpoints [44] and [45].

Tension headache and migraine have historically relied on the use of diaries for diagnosis and treatment. Clinical studies now incorporate PROMs as primary, coprimary, and secondary endpoints. Widely used PROMs with correlations to diaries include the Migraine Disability Assessment and Headache Impact Test [46].