Presentation Authors: Kevin McVary*, Maywood, IL, Tyson Rogers, Minneapolis, MN, Christopher Cantrill, San Antonio, TX, Claus Roehrborn, Dallas, TX
Introduction: Relief of lower urinary tract symptoms (LUTS), those due to benign prostatic hyperplasia (BPH), is only relevant if commensurate with improving patients&[prime] perception of improved quality of life (QOL). We evaluated 4 year outcome data from the randomized double-blind, controlled trial (RCT) of water vapor thermal therapy for treatment of moderate-to-severe LUTS/BPH, and also determined the minimal important differences (MIDs) in International Prostate Symptom Scores (IPSS) associated with meaningful changes in QOL.
Methods: Total 188 subjects; 135 men â‰¥50 years old with IPSS â‰¥13, maximum flow rate (Qmax) â‰¤15 ml/s and prostate volume 30-80 cm3 treated once in the RCT for RezumÂ® System thermal therapy were followed for 4 years and a subset of 53 men who requalified for cross-over from control (sham rigid cystoscopy) to active treatment were followed for 3 years. IPSS-QOL was used in a method for anchor-based analysis to determine MID in IPSS point changes related to degrees of improved QOL for each severity category of LUTS.
Results: Mean symptom relief was significantly improved within 3 months or less (IPSS 50%, QOL 46%, Qmax 69%, BPH Impact Index 46%) after thermal therapy and remained consistently durable (IPSS 46%, QOL 42%, Qmax 50%, BPH Impact Index 51%) throughout 4 years (p < 0.0001); outcomes were similarly sustained in crossover subjects at 3 years. Targeted ablation was to all prostate zones including an obstructing median lobe and/or enlarged central zone. No late related adverse events occurred and no de novo erectile dysfunction was reported. IPSS and QOL scores are very strongly correlated (Spearman correlation coefficient = 0.67 - 0.72) after water vapor thermal therapy. The estimated mean change in IPSS score from baseline corresponding to a one point QOL change for each LUTS severity level is approximately -5 points for mild (IPSS 13-19), -8.2 for moderate (IPSS 20-26) and -11.7 for severe LUTS (IPSS 27-35), p < 0.0001. The MID was quite consistent across time points over 3 years. In general, men had a mean ~50% improvement in QOL (from &[Prime]mostly dissatisfied&[Prime] to &[Prime]mostly satisfied&[Prime] with urinary condition; score decrease from 4 to 2).
Conclusions: The MID offers a threshold above which the outcome is experienced as providing a noticeable improvement in QOL by the patient. Water vapor thermal therapy provided effective symptom relief and improved QOL that remains durable for over 4 years. This minimally invasive therapy is applicable to all prostate zones with procedures performed under local anesthesia in an office setting.
Source of Funding: Boston Scientific