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Randomized Controlled Trial
. 2024 Mar 4;7(3):e241784.
doi: 10.1001/jamanetworkopen.2024.1784.

Multicomponent Intervention for Overactive Bladder in Women: A Randomized Clinical Trial

Satoshi Funada  1   2   3 , Yan Luo  2 , Ryuji Uozumi  4 , Norio Watanabe  5 , Takayuki Goto  1 , Hiromitsu Negoro  6 , Kentaro Ueno  7 , Kentaro Ichioka  8 , Takehiko Segawa  9 , Tatsuo Akechi  3 , Osamu Ogawa  1 , Shusuke Akamatsu  1 , Takashi Kobayashi  1 , Toshi A Furukawa  2
Affiliations
Randomized Controlled Trial

Multicomponent Intervention for Overactive Bladder in Women: A Randomized Clinical Trial

Satoshi Funada et al. JAMA Netw Open. .

Abstract

Importance: Although the cognitive components of behavioral therapy for overactive bladder (OAB) are widely recognized, there is a lack of studies evaluating the effectiveness of multicomponent interventions that include cognitive components as a treatment for OAB.

Objective: To examine the efficacy of a multicomponent intervention in improving health-related quality of life (HRQOL) for women with moderate to severe OAB.

Design, setting, and participants: This multicenter, open-label, randomized clinical trial was conducted in Japan among women aged 20 to 80 years who had moderate to severe OAB. Participants were recruited from 4 institutions between January 16, 2020, and December 31, 2022, through self-referral via advertisement or referral from the participating institutions.

Interventions: Participants were randomized 1:1 by minimization algorithm using an internet-based central cloud system to four 30-minute weekly sessions of a multicomponent intervention or waiting list. Both groups continued to receive baseline treatment throughout the study period.

Main outcomes and measures: The primary outcome was the least-squares mean changes from baseline through week 13 in HRQOL total scores of the OAB questionnaire between 2 groups. Secondary outcomes included OAB symptom score and frequency volume chart.

Results: A total of 79 women were randomized to either the intervention group (39 participants; mean [SD] age, 63.5 [14.6] years) or the waiting list control group (40 participants; mean [SD] age, 63.5 [12.9] years). One participant from each group dropped out from the allocated intervention, while 5 participants in the intervention group and 2 in the control group dropped out from the primary outcome assessment at week 13. Thirty-six participants (92.3%) in the intervention group and 35 (87.5%) in the control group had moderate OAB. The change in HRQOL total score from baseline to week 13 was 23.9 points (95% CI, 18.4-29.5 points) in the intervention group and 11.3 points (95% CI, 6.2-16.4 points) in the waiting list group, a significant difference of 12.6 points (95% CI, 6.6-18.6 points; P < .001). Similar superiority of the intervention was confirmed for frequency of micturition and urgency but not for OAB symptom score.

Conclusions and relevance: These findings demonstrate that a multicomponent intervention improves HRQOL for women with moderate to severe OAB and suggest that the cognitive component may be an effective treatment option for women with OAB.

Trial registration: UMIN Clinical Trials Registry Identifier: UMIN000038513.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Funada reported receiving grants from the KDDI Foundation and Pfizer Health Research Foundation outside the submitted work. Dr Uozumi reported receiving personal fees from Eisai, Sawai Pharmaceutical, SBI Pharmaceuticals, Daiichi Sankyo, Statcom, and EPS Corporation; lecture fees from Janssen Pharmaceuticals and SAS Institute Japan; and a Grant-in-Aid for Scientific Research (KAKENHI) from the Japan Society for the Promotion of Science (JSPS) outside the submitted work. Dr Goto reported receiving grants from AstraZeneca and a Grant-in-Aid for Scientific Research (KAKENHI) from JSPS outside the submitted work. Mr Ueno reported receiving lecture fees from Sumitomo Pharma outside the submitted work. Dr Akechi reported receiving lecture fees from AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Janssen Pharmaceuticals, Kowa, Kyowa Kirin, Lundbeck, MSD, Meiji-Seika Pharma, Mochida, Nipro, Otsuka, Pfizer, Sumitomo Pharma, Takeda, Tsumura, and Viatris and royalties from Igaku-Shoin outside the submitted work. Prof Furukawa reported receiving personal fees from Boehringer Ingelheim, Daiichi Sankyo, DT Axis, Kyoto University, Shionogi, Sony, and UpToDate and grants from Shionogi outside the submitted work and having patents pending for intellectual properties for the Kokoro-app licensed to Mitsubishi-Tanabe. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram of Trial Participation
Figure 2.
Figure 2.. Least-Squares Mean (LSM) Changes in Overactive Bladder Questionnaire Scores From Baseline Over Time by Treatment Group
See this image and copyright information in PMC

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