Clinically and Statistically Significant Changes Seen in Sham Surgery Arms of Randomized, Controlled Benign Prostatic Hyperplasia Surgery Trials

Purpose: Medication trials frequently involve a placebo arm to more fairly assess the efficacy of the study drug. However, benign prostatic hyperplasia surgery trials rarely include a sham surgery group due to the inherent risks associated with simulating treatment in these patients. As a result the placebo response to sham surgery for benign prostatic hyperplasia is largely unknown.

Materials And Methods: We systematically reviewed the available literature to look for randomized, controlled trials involving endoscopic or intraprostatic injection benign prostatic hyperplasia treatments that included a sham surgical arm from January 1990 to February 2015. Studies that included an objective symptom questionnaire and maximum urinary flow at 3 months were included. Results were analyzed together with weighting based on study sample size.

Results: The initial search yielded a total of 1,998 potential studies. After reviewing abstracts and full text articles 14 randomized, controlled trials were included in some part. An average decrease from 22.3 to 16.7 (-27%) was seen in studies of the AUASS (American Urological Association symptom score) 3 months after a sham endoscopic procedure (p=0.0003) with an increase in maximum urinary flow of 1.3 ml per second (14%, p=0.001) at 3 months. Prostate injection based studies at 3 months were similar with a decrease from 21.3 to 15.7 (-26%, p<0.001). Maximum urinary flow increased by 2.0 ml per second (23%, p=0.043).

Conclusions: Sham controlled endoscopic and injection benign prostatic hyperplasia interventions demonstrate a considerable and statistically significant change in symptom scores and maximum urinary flow, which is comparable to the response seen in medication trials. Future uncontrolled benign prostatic hyperplasia surgical trials should consider these findings when interpreting outcomes.