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Twelve-week, prospective, open-label, randomized trial on the effects of an anticholinergic agent or antidiuretic agent as add-on therapy to an alpha-blocker for lower urinary tract symptoms

Authors Shin YS, Zhang LT, Zhao C, Kim YG, Park JK

Received 17 March 2014

Accepted for publication 23 April 2014

Published 10 July 2014 Volume 2014:9 Pages 1021—1030

DOI https://doi.org/10.2147/CIA.S64194

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Yu Seob Shin,1 Li Tao Zhang,1 Chen Zhao,2 Young Gon Kim,1 Jong Kwan Park1

1Department of Urology, Chonbuk National University Medical School, and Institute for Medical Sciences, Chonbuk National University and Biomedical Research Institute and Clinical Trial Center of Medical Device of Chonbuk National University Hospital, Jeonju, South Korea; 2Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai Institute of Andrology, Shanghai, People’s Republic of China

Purpose: The effects of an anticholinergic or antidiuretic agent as add-on therapy to an ­alpha-blocker for lower urinary tract symptoms (LUTS) according to a voiding diary in 3 days are unknown. We prospectively investigated the efficacy of an anticholinergic or antidiuretic agent as add-on therapy for nocturia in men previously treated with an alpha-blocker for LUTS.
Subjects and methods: Patients were randomly subdivided into two groups. All patients had a 4-week washout. Group A had alpha-blocker for 4 weeks, then an alpha-blocker plus an anticholinergic agent for 4 weeks, and, finally, 4 weeks of an alpha-blocker plus an antidiuretic agent. Group B had an alpha-blocker for 4 weeks, then an alpha-blocker plus an antidiuretic agent for 4 weeks, and, finally, 4 weeks of an alpha-blocker plus an anticholinergic agent. In both groups, patients were subdivided into nocturnal polyuria, decreased nocturnal bladder capacity (NBC), or nocturia by both causes subgroups. A 3-day voiding diary, total International Prostate Symptom Score (IPSS), IPSS sub-scores, Overactive Bladder Symptom Score, uroflowmetry, and post-void residual urine volume, were assessed at baseline, and at 4, 8, and 12 weeks.
Results: A total of 405 patients completed the study. During treatment, the changes from baseline in total IPSS and IPSS sub-scores were significantly decreased at 4 weeks and were maintained for 12 weeks. In the nocturnal polyuria subgroup of Groups A and B, the number of episodes of nocturia in 3 days, nocturnal urine volume, and nocturnal index were significantly decreased using an alpha-blocker plus an antidiuretic agent. In the decreased NBC subgroup of Groups A and B, IPSS storage sub-score, Overactive Bladder Symptom Score, number of episodes of nocturia in 3 days, number of episodes of urgency in 3 days, and NBC index were all significantly decreased using an alpha-blocker plus an anticholinergic agent.
Conclusion: An anticholinergic agent or antidiuretic agent as an add-on therapy in men previously treated with an alpha-blocker improves nocturia including LUTS.

Keywords: LUTS, nocturia, nocturnal bladder capacity, benign prostatic hyperplasia

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