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- Title
Multicomponent Intervention for Overactive Bladder in Women: A Randomized Clinical Trial.
- Authors
Funada, Satoshi; Luo, Yan; Uozumi, Ryuji; Watanabe, Norio; Goto, Takayuki; Negoro, Hiromitsu; Ueno, Kentaro; Ichioka, Kentaro; Segawa, Takehiko; Akechi, Tatsuo; Ogawa, Osamu; Akamatsu, Shusuke; Kobayashi, Takashi; Furukawa, Toshi A.
- Abstract
Key Points: Question: What is the efficacy of a multicomponent intervention with cognitive components in improving health-related quality of life (HRQOL) for women with moderate to severe overactive bladder (OAB)? Findings: In this randomized clinical trial of 79 women, those who underwent four 30-minute weekly sessions of a multicomponent intervention had a significantly and clinically significant improvement in HRQOL scores compared with the waiting list control group. Meaning: These findings provide evidence to support a multicomponent intervention with cognitive components as an effective treatment option for women with moderate to severe OAB by improving HRQOL. This randomized clinical trial examines the efficacy of a multicomponent intervention in improving health-related quality of life for women with moderate to severe OAB. 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
- Subjects
JAPAN; SELF-evaluation; EFFECT sizes (Statistics); REPEATED measures design; T-test (Statistics); RESEARCH funding; EVALUATION of human services programs; STATISTICAL sampling; HUMAN research subjects; QUESTIONNAIRES; SAMPLE size (Statistics); RANDOMIZED controlled trials; SEVERITY of illness index; DESCRIPTIVE statistics; QUALITY of life; RESEARCH; INFORMED consent (Medical law); COGNITIVE therapy; HEALTH outcome assessment; PSYCHOLOGICAL tests; SOCIODEMOGRAPHIC factors; ADVERSE health care events; CONFIDENCE intervals; DATA analysis software; COMPARATIVE studies; OVERACTIVE bladder; ALGORITHMS; TIME
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe241784
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.1784