Hypothesis / aims of study
Minimally invasive surgical therapies for BPH should be thoroughly evaluated in various patient populations, including those in urinary retention, and performance in the real world should reflect that seen in controlled studies. Here, we report outcomes of PUL from retention patients in the real-world and the controlled PULSAR study, with newly analyzed urodynamics data.
study design, materials and methods
The controlled PULSAR study followed 52 retention subjects with ≥ 1 failed TWOC while on alpha blocker and evaluated outcomes for 12 months after PUL. Outcomes included SHIM, satisfaction, and urodynamics. The Real-World Retrospective (RWR) database for PUL included 512 subjects who were in active urinary retention status at the time of the PUL procedure, across 22 international sites. Comparisons were evaluated between RWR retention (RWR-r) and PULSAR subjects in baseline demographics, absolute IPSS, QoL, Qmax, and PVR, and AE and catheter-independence rates.
Baseline characteristics were similar between RWR-r subjects and PULSAR subjects in age (average of 71yo for both groups), prostate size (48cc vs. 55cc), and number of implants per patient (4.7 vs. 4.8). In the PULSAR study, 90% of PULSAR subjects felt better after PUL and 88% indicated they would recommend the procedure. Satisfaction was high among PULSAR subjects on average, and there was no difference in duration of catheterization prior to PUL between the highest and least satisfied patients (140d vs 114d, respectively, correlation p-value 0.5). Erectile function was preserved in PULSAR subjects, as measured via SHIM. Twelve PULSAR subjects had urodynamics available; of those, pdet@Qmax and BOOI improved from baseline by 23% and 41% respectively and 5 moved out of the obstructed zone (Fig 1). Among subjects who remained in the obstructed category at 12 months, 86% were catheter-independent and 83% reported feeling very much better since their PUL procedure. Outcomes of IPSS, Qmax, and PVR outcomes were equivalent between RWR-r and PULSAR subjects at 12 months; QoL was significantly better for PULSAR than RWR-r subjects (1.4 vs. 2.1, respectively). Catheter-independence rates were better for RWR-r subjects at 1 month after PUL (81% vs. 60%) and at longest available follow-up (84% vs 73%). AEs overall were not elevated in RWR-r subjects compared to PULSAR, and most AEs in both studies were mild-moderate and transient.
Interpretation of results
In the controlled PULSAR study, retention patients were highly satisfied after PUL, with improvements in urodynamics and preservation of erectile function. Outcomes of real-world retention patients largely mirrored those from the controlled PULSAR trial and demonstrated superior rates of catheter-independence.
The large multicenter RWR of PUL and the controlled PULSAR study reveal stable and largely consistent outcomes in retention patients at 12 months, indicating that PUL is effective and safe and may be a viable option for this population of BPH patients.
Funding NeoTract/Teleflex Clinical Trial Yes Registration Number NCT03194737 RCT No Subjects Human Ethics Committee Health and Care Research Wales Helsinki Yes Informed Consent Yes