Introduction: Five year results of the prospective, randomized controlled trial of water vapor thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia
Methods: 197 subjects =50 years old with IPSS =13, maximum flow rate (Qmax) 5-15 ml/s and prostate volume 30-80 cc were randomized 2:1 (thermal therapy Rezum System: sham control rigid cystoscopy). Thermal therapy involved injection of water vapor into obstructive tissue, possibly including the middle lobe and/or enlarged central zone. The primary outcome was change in IPSS; other outcomes assessed included changes in quality of life and Qmax. The study assessed each subject for retreatment of BPH after the index procedure. Subjects who received secondary surgical treatment for LUTS/BPH were included in the surgical retreatment results and subjects who initiated BPH medication (alpha-blocker, or 5-ARIs) were included in the medication retreatment results.
Results: In the randomized comparison at 3 months, mean IPSS reduction from baseline was 11.2 and 4.3 pts for active (n=136) and control (n=61) subjects, (Rezum: Sham respectively) p<0.0001. Reduction in IPSS was sustained in the active treatment arm at five years, with a mean reduction from baseline of 10.4 points. The change from baseline in maximum urinary flow rate was 6.4 ml/sec at 3 months and 4.3 ml/sec at five years. Within the active treatment group, the surgical retreatment rate was 4.4%, while 11.1% of the treatment-arm subjects initiated BPH medication at 5 years. On a per subject basis, improvements of symptoms (50% IPSS), quality of life (46% IPSS-QOL, 46% BPH Impact Index) and flow rate (69% Qmax) occurring within =3 months were sustained to five years with improvements of 48%, 46%, 49%, and 49%, respectively (p<0.0001).
Conclusions: Treatment-arm results show that the minimally invasive water vapor thermal therapy offers significant improvements in LUTS, QOL and flow rate sustained through 5 years. Source of