Background
Erectile dysfunction (ED) and ejaculatory dysfunction (EjD) are known outcomes of traditional surgery and some pharmacotherapies for treatment of benign prostatic hyperplasia (BPH). Minimally invasive treatment options, including water vapor thermal therapy (WVTT), are now available to treat lower urinary tract symptoms (LUTS) due to BPH.
Aim
The objective of this analysis was to evaluate long-term impact of a single water vapor thermal therapy procedure on erectile and ejaculatory function in subjects enrolled in the Rezum II prospective, multicenter, randomized, blinded controlled trial.
Methods
Fifteen centers enrolled 197 subjects with International Prostate Symptom Score (IPSS) ≥ 13, maximum flow rate (Qmax) ≤ 15 mL/s, and prostate volume 30-80 cc. Subjects were randomized (2:1) to (WVTT) or sham procedure (control) and followed for 5 years. Erectile and ejaculatory functions were quantitatively assessed at baseline and yearly thereafter. After 3 months, control subjects could opt to requalify for cross-over to WVTT and were followed for 5 years. Results of the per protocol analysis were reported previously. The current post hoc analysis was performed on all treated subjects who were sexually active at baseline with no other surgical or medical management for BPH during the 5-year study period.
Outcomes
LUTS was evaluated using IPSS, Benign Prostatic Hyperplasia Impact Index (BPHII), and Qmax. Sexual function was assessed using the International Index of Erectile Function (IIEF-EF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).
Results
A total of 197 subjects (136 treated, 61 control) were enrolled in the study, and 53 control subjects opted to cross-over and receive WVTT. All subgroups experienced significant, durable improvement in IPSS (P < .0001). Subjects with normal sexual function at baseline had little change in function over 5 years (IIEF-EF: -2.4 ± 8.9, P = .1414; MSHQ-EjD Function: -1.6 ± 3.2, P = .0083; MSHQ-EjD Bother: -0.5 ± 1.6, P = .1107). Subjects with baseline medical history of ED and EjD showed slight decline over time that was not clinically significant (ED, IIEF-EF: -3.0 ± 10.1, P = .1259; MSHQ EjD Function: -2.3 ± 4.7, P = .0158; MSHQ-EjD Bother: -0.1 ± 2.6, P = .7764; EjD, IIEF-EF: -4.1 ± 9.2, P = .0127; MSHQ EjD Function: -1.6 ± 4.8, P = .1970; MSHQ-EjD Bother: -0.4 ± 2.6, P = .440).
Clinical implications
Treatment for BPH with Rezum durably improved IPSS without clinically significant impact on sexual function. Patients with baseline ED/EjD may expect continued decline from other causes but are unimpacted by the therapy.
Strengths & limitations, conclusion
The results are limited by the post-hoc nature of the analysis and attrition over the 5-year follow-up but provide long-term evidence of durable outcomes after treatment with Rezum without impact on sexual function scores.
