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Meta-Analysis of the Efficacy and Safety of Imidafenacin for Overactive Bladder Induced by Benign Prostatic Hyperplasia in Men Receiving Alpha-Blocker Therapy

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Meta-Analysis of the Efficacy and Safety of Imidafenacin for Overactive Bladder Induced by Benign Prostatic Hyperplasia in Men Receiving Alpha-Blocker Therapy INTERNATIONAL NEUROUROLOGY JOURNAL INTERNATIONAL INJ pISSN 2093-4777 eISSN 2093-6931 Original Article Int Neurourol J 2020;24(4):365-374 NEU INTERNATIONAL RO UROLOGY JOURNAL https://doi.org/10.5213/inj.2040146.073 pISSN 2093-4777 · eISSN 2093-6931 Volume 19 | Number 2 June 2015 Volume pages 131-210 Official Journal of Korean Continence Society / Korean Society of Urological Research / The Korean Children’s Continence and Enuresis Society / The Korean Association of Urogenital Tract Infection and Inflammation einj.org Mobile Web Meta-Analysis of the Efficacy and Safety of Imidafenacin for Overactive Bladder Induced by Benign Prostatic Hyperplasia in Men Receiving Alpha-Blocker Therapy Tong Cai 1,2,*, Ning Wang2,*, Liye Liang3, Zhongbao Zhou2, Yong Zhang4, Yuanshan Cui2,4 1School of Clinical Medicine, Binzhou Medical University, Yantai, Shandong, China 2Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China 3Department of Urology, Rizhao traditional Chinese Hospital, Rizhao, Shandong, China 4Department of Urology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China Purpose: The aim of this meta-analysis was to evaluate the efficacy and safety of imidafenacin for overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving alpha-blocker monotherapy. Methods: We performed a systematic research of the PubMed, Embase, and Cochrane Library databases, and searched for studies about alpha-blocker with or without imidafenacin treatment for OAB in patients with BPH. We also investigated the original references of the included texts. Results: Four randomized controlled trials including 779 participants with BPH (389 in the alpha-blocker+imidafenacin group and 390 in the alpha-blocker only group) were studied. The main efficacy endpoint was the Overactive Bladder Symp- tom Score, which showed a mean difference of -1.88 (95% confidence interval, -2.32 to -1.44; P<0.00001), suggesting that al- pha-blocker and imidafenacin treatment was effective in treating men with OAB. As other primary efficacy end points, the In- ternational Prostate Symptom Score (IPSS) total score (P=0.47), the IPSS storage symptom score (P=0.07), the IPSS voiding symptom score (P=0.60), and the IPSS quality of life score (P=0.18) indicated that 2 methods had no significant differences in treating men with OAB. In terms of safety, which was assessed using postvoid residual volume (P=0.05) and maximum flow rate (P=0.53), the analysis suggested that combination treatment was very well tolerated. Conclusions: This study suggested that imidafenacin plus alpha-blocker was an efficacious and safe treatment for OAB symp- toms in BPH patients. Keywords: Imidafenacin; Alpha-blocker; Urinary bladder, Overactive; Prostatic hyperplasia; Lower urinary tract symptoms; Randomized controlled trial • Fund/Grant Support: This work was supported by the National Nature Science Foundation of China (Nos. 81870525; 81801429), Beijing Mu- nicipal Administration of Hospitals’ Ascent Plan, Code: DFL20190502 and Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support, Code: ZYLX201820. • Conflict of Interest: No potential conflict of interest relevant to this article was reported. INTRODUCTION nary tract symptoms (LUTS), benign prostatic hyperplasia (BPH) often causes urinary tract dysfunction in men aged 50 As one of the most common conditions that cause lower uri- years and older, with a prevalence of 19%–30% [1,2]. The Inter- Corresponding author: Yuanshan Cui https://orcid.org/0000-0002-6688-449X This is an Open Access article distributed under the terms of the Cre- Department of Urology, Beijing Tiantan Hospital, Capital Medical University, ative Commons Attribution Non-Commercial License (https://creative- No.119 South 4th Ring West Road, Fengtai District, Beijing 100070, China commons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distri- E-mail: [email protected] bution, and reproduction in any medium, provided the original work is properly cited. *Tong Cai and Ning Wang contributed equally to this study as co-first authors. Submitted: May 6, 2020 / Accepted after revision: June 16, 2020 Copyright © 2020 Korean Continence Society www.einj.org INJ Cai, et al. • The Efficacy and Safety of Imidafenacin on OAB Induced by BPH national Continence Society defined overactive bladder (OAB) without imidafenacin treatment for OAB in patients with BPH. as urinary urgency with urinary frequency, nocturia, and some- We searched using the following keywords: “alpha-blocker,” times urgency incontinence. In the course of everyday life, OAB “imidafenacin,” “RCT,” “BPH,” “male-LUTS” and “OAB.” We is the most inconvenient symptom for men with BPH [3]. At also examined original references of the texts that were included. present, in order to relieve the symptoms of BPH, the main treatment pattern is drug therapy, especially alpha-blockers. Inclusion Criteria Currently, alpha-blockers are widely used as the first-line thera- RCTs were included if they met the following criteria: (1) the py for BPH, but it is difficult to improve the storage symptoms RCT was topically relevant to this meta-analysis (i.e., it analyzed of OAB with alpha-blockers alone. However, anticholinergic alpha-blocker with or without imidafenacin treatment for OAB agents have been recommended to treat the symptoms of OAB, symptoms resulting from BPH); (2) the full text was available as they have been found to be efficient in alleviating storage and the study was an RCT; and (3) similar observation indica- symptoms for men with BPH [4-7]. tors were used to compare the alpha-blocker+imidafenacin Imidafenacin, a selective antimuscarinic drug, was proposed group and the alpha-blocker only group in every RCT. to treat the symptoms of OAB. Recent studies have shown that The following studies were excluded: (1) those that were not imidafenacin can decreased urine volume via suppression of C- RCTs, such as abstracts, reviews, or comments; and (2) those fibers and reduced nocturnal urine volume for OAB patients that involved catheterization or patients with a prior diagnosis [8]. In some studies, anticholinergics combined with alpha- of neurogenic bladder. blockers have shown demonstrable effects in treating OAB in If a duplicate study had been published in different journals men with BPH, but their clinical effect is limited [9]. In clinical or at different time points, we included only the most recently practice, there have been concerns that anticholinergic agents published study. However, every study was included if different are infrequently used to treat BPH in patients because the in- measures were evaluated. Fig. 1 presents a flow chart of the se- hibitory effect of anticholinergics, which produce detrusor lection process for the study. muscle contractions that aggravate urinary symptoms, may in- crease the risk of the numbers of adverse events or acute uri- Quality Assessment nary retention. Urinary retention can reduce patients’ quality of The Jadad scale was used to determine the quality of the re- life (QoL). Research has shown an incidence of 68 per 10,000 person-years among men [10]. Dry mouth, as one of the most 91 Articles were identified including: common and problematic side effects, can often lead to discon- PubMED: 68 articles tinuation of anticholinergic therapy [11]. On the basis of the EMBASE: 11 articles Cochrane Library databases: 12 articles 2019 European Association of Urology Guideline, patients with BPH who have OAB symptoms may use anticholinergic agents simultaneously with an alpha-blocker. Meanwhile, some ran- On the basis of titles and abstracts, 84 articles were excluded. domized controlled trials (RCTs) and other studies have sought to demonstrate the effects of anticholinergic agents [12-14]. In order to evaluate the curative effect and safety of combined 7 Relevant articles were included. alpha-blocker and imidafenacin treatment for persistent OAB associated with BPH, we performed a systematic review and 3 Articles lack useful data. meta-analysis of RCTs. 4 Articles with 4 RCTs included in the final MATERIALS AND METHODS analysis about combination therapy of imidafenacin and alpha-blocker on OAB induced by BPH. Information Sources and Literature Search We systematically retrieved articles from the PubMed, Embase, Fig. 1. Flowchart of the study selection process. RCT, random- and the Cochrane Library databases published before January ized controlled trial; OAB, overactive bladder; BPH, benign 2020, and searched for studies about alpha-blocker with or prostatic hyperplasia. 366 www.einj.org Int Neurourol J December 31, 2020 Cai, et al. • The Efficacy and Safety of Imidafenacin on OAB Induced by BPH INJ trieved RCTs [15]. In the meta-analysis, several metrics were order to evaluate the difference between the start and the end- used to assess the quality of the individual studies, including the point in each RCT, our team analyzed changes in the total assignment method of patients, the concealment of allocation, OABSS, the IPSS total score, the IPSS storage symptoms score, the blinding method, the results of loss to follow-up, and the IPSS voiding symptoms score, the IPSS QoL score, PVR, whether there was a calculation of sample size or intention-to- and Qmax. The mean difference (MD) was used to evaluate treat analysis. The studies were then classified qualitatively -us continuous data, and odds ratios (ORs) with 95% confidence ing the
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