Author's Accepted Manuscript Clinically and statistically significant changes seen in sham surgery arms of randomized controlled benign prostatic hyperplasia surgery trials Charles Welliver , Michael Kottwitz , Paul Feustel , Kevin McVary
PII: DOI: Reference:
S0022-5347(15)04305-0 10.1016/j.juro.2015.06.091 JURO 12731
To appear in: The Journal of Urology Accepted Date: 11 June 2015 Please cite this article as: Welliver C, Kottwitz M, Feustel P, McVary K, Clinically and statistically significant changes seen in sham surgery arms of randomized controlled benign prostatic hyperplasia surgery trials, The Journal of Urology® (2015), doi: 10.1016/j.juro.2015.06.091. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain.
Embargo Policy All article content is under embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date. Questions regarding embargo should be directed to [email protected].
ACCEPTED MANUSCRIPT
Title: Clinically and statistically significant changes seen in sham surgery arms of randomized controlled benign prostatic hyperplasia surgery trials. Authors: Charles Welliver1, Michael Kottwitz2, Paul Feustel3, Kevin McVary2
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1-Albany Medical College, Department of Surgery, Division of Urology 2-Southern Illinois University School of Medicine, Department of Surgery, Division of Urology
SC
3-Albany Medical College, Center for Neuropharmacology and Neuroscience
Corresponding Author:
Albany Medical College 23 Hackett Blvd Albany, NY 12208 P: 5182623296 F: 5182624784
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Charles Welliver, MD
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Abstract Word Count: 250/250
Manuscript Word Count: 2318/2500
AC C
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Keywords: benign prostatic hyperplasia, sham, lower urinary tract symptoms, placebo
ACCEPTED MANUSCRIPT
Abstract: Introduction:
RI PT
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:
M AN U
SC
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.
Conclusion:
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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
PII: DOI: Reference:
S0022-5347(15)04305-0 10.1016/j.juro.2015.06.091 JURO 12731
To appear in: The Journal of Urology Accepted Date: 11 June 2015 Please cite this article as: Welliver C, Kottwitz M, Feustel P, McVary K, Clinically and statistically significant changes seen in sham surgery arms of randomized controlled benign prostatic hyperplasia surgery trials, The Journal of Urology® (2015), doi: 10.1016/j.juro.2015.06.091. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain.
Embargo Policy All article content is under embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date. Questions regarding embargo should be directed to [email protected].
ACCEPTED MANUSCRIPT
Title: Clinically and statistically significant changes seen in sham surgery arms of randomized controlled benign prostatic hyperplasia surgery trials. Authors: Charles Welliver1, Michael Kottwitz2, Paul Feustel3, Kevin McVary2
RI PT
1-Albany Medical College, Department of Surgery, Division of Urology 2-Southern Illinois University School of Medicine, Department of Surgery, Division of Urology
SC
3-Albany Medical College, Center for Neuropharmacology and Neuroscience
Corresponding Author:
Albany Medical College 23 Hackett Blvd Albany, NY 12208 P: 5182623296 F: 5182624784
M AN U
Charles Welliver, MD
TE D
Abstract Word Count: 250/250
Manuscript Word Count: 2318/2500
AC C
EP
Keywords: benign prostatic hyperplasia, sham, lower urinary tract symptoms, placebo
ACCEPTED MANUSCRIPT
Abstract: Introduction:
RI PT
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:
M AN U
SC
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.
Conclusion:
TE D
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
