Efficacy of RWT and TURP in BPH Men Refractory to Medical Therapy : Analysis of 2 FDA Clinical Trials
Introduction
One of the indication for benign prostate hyperplasia (BPH) surgical therapy is failure to improve with medical therapy. Most of the Federal Drug Administration (FDA) registered randomized clinical trials (RCTs) for minimally invasive surgical therapies (MISTs) are designed to be compared to either sham or placebo while off medical therapy at baseline, and as an alternative to medical therapy. There is lack of data on the efficacy of MISTs in patients with true medical therapy failure.
Aim
The efficacy of robotic water jet ablation therapy (RWT) and TURP has been compared in patients who have failed to improve with medical therapy.
Method
Study Design
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Post hoc analysis of prospective, double-blind, multicenter international clinical trials - WATER and WATER II
Treatment Strategy
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WATER trial compared the safety and efficacy of RWT and TURP in LUTS/BPH patients aged 45-80 years with a prostate of 30-80 cm
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WATER II included LUTS/BPH men with prostate size 80-150 cm on aquablation
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Both clinical trials did not implement a drug washout period
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Only men who had alpha-blockers (AB) and 5-alpha-reductase inhibitors (5-ARIs) prior to undergoing RWT or TURP were recruited
Endpoints
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Post-void residual volume (PVR)
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Peak urinary flow rate (Qmax)
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International prostate symptom score (IPSS)
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Quality of life score (QoL)
Results
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Out of the 185 men, 79% underwent RWT and AB and/or 5-ARIs usage at baseline were reported in 146 and 39 patients who underwent RWT (prostate sizes up to 150 cc) and TURP (prostate sizes up to 80 cc) respectively
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Baseline median IPSS, QoL, Qmax and PVR were 24, 5, 8.9 and 95 respectively
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There were no significant differences in the functional outcomes between Aquablation and TURP at baseline and at 36-month
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In patients who underwent RWT, erectile dysfunction and ejaculation dysfunction (EjD) were higher in patients who were not on BPH medications at baseline, however the difference was insignificant in both trials
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Both RWT and TURP demonstrated group statistical improvements in PVR, Qmax, IPSS, and QoL at 36-month compared to baseline in cohort of true medical failure
Conclusion
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Both robotic water jet ablation therapy (RWT) and transurethral resection of the prostate (TURP) are effective BPH therapy in patients refractory to medical therapy
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RWT was effective in larger prostate size range.
Can J Urol. 2023 Feb;30(1):11408-413.
