Multicomponent Intervention for Overactive Bladder in Women

Author:

Funada Satoshi123,Luo Yan2,Uozumi Ryuji4,Watanabe Norio5,Goto Takayuki1,Negoro Hiromitsu6,Ueno Kentaro7,Ichioka Kentaro8,Segawa Takehiko9,Akechi Tatsuo3,Ogawa Osamu1,Akamatsu Shusuke1,Kobayashi Takashi1,Furukawa Toshi A.2

Affiliation:

1. Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan

2. Department of Health Promotion and Human Behavior, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan

3. Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan

4. Department of Industrial Engineering and Economics, Tokyo Institute of Technology, Tokyo, Japan

5. Department of Psychiatry, Soseikai General Hospital, Kyoto, Japan

6. Department of Urology, Institute of Medicine, University of Tsukuba, Ibaraki, Japan

7. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

8. Ichioka Urological Clinic, Kyoto, Japan

9. Department of Urology, Kyoto City Hospital, Kyoto, Japan

Abstract

ImportanceAlthough 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsParticipants 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 MeasuresThe 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.ResultsA 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 RelevanceThese 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 RegistrationUMIN Clinical Trials Registry Identifier: UMIN000038513

Publisher

American Medical Association (AMA)

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