INTRODUCTION: While medication trials frequently involve a placebo arm to more fairly assess efficacy of the study drug, benign prostatic hyperplasia (BPH) surgery trials rarely include a sham surgery group due to the inherent risks associated with simulating treatment in these patients. Resultantly, the placebo response to a sham surgery for BPH is largely unknown.
METHODS: A systematic review of available literature was undertaken looking for randomized controlled trials (RCTs) involving endoscopic or intraprostatic injection BPH treatments that included a sham surgical arm from January 1990 to February 2015. Studies that included an objective symptom questionnaire and maximum urinary flow (Qmax) at 3 months were included. Results were analyzed together with weighting based on study sample size.
RESULTS: Initial search yielded a total of 1998 potential studies. After review of abstracts and full text articles, a total of 14 RCTs were included in some part. An average decrease from 22.3 to 16.7 (-27%) was seen in studies looking at the AUASS at 3 months after sham endoscopic procedure (p=0.0003) with an increase in Qmax of 1.3mL/sec (14%, p=0.001) at 3 months. Decreases in prostate injection based studies at three months were similar with a decrease from 21.3 to 15.7 (-26%, p<0.001). Qmax increased by 2.0mL/sec (23%, p=0.043).
CONCLUSION: Sham controlled endoscopic and injection BPH interventions demonstrate a considerable and statistically significant change in symptom scores and Qmax that is comparable to the response seen in medication trials. Future uncontrolled BPH surgical trials should consider these findings when interpreting their outcomes.
J Urol. 2015 Jul 1. pii: S0022-5347(15)04305-0. doi: 10.1016/j.juro.2015.06.091. [Epub ahead of print]
Welliver C1, Kottwitz M2, Feustel P3, McVary K2.
1 Albany Medical College, Department of Surgery, Division of Urology.
2 Southern Illinois University School of Medicine, Department of Surgery, Division of Urology.
3 Albany Medical College, Center for Neuropharmacology and Neuroscience.