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.
| Specialty | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) | |
| General Internal Medicine-Primary Care(US) | |
| Gynecology |
As a family physician, this trial is useful to support multicomponent interventions for overactive bladder (OAB). There is low- or very low-certainty evidence about bladder training for treating OAB (Funada S. et al, 2023) and this trial contributes to better understanding in managing OAB.
Seems to make sense. Question of cost and availability.
Undoubtedly, this is a well done and very well presented study. A difference is found in the score of some scales that are not used in routine clinical care, so it is difficult to approximate the difference that women have in real life. What do 12 scale points represent? In clinically identifiable outcomes such as episodes of urgency or urge incontinence, no differences were found with the intervention (Supplementary e-4 Table).
This article is very useful for gynecologists. The findings demonstrate that a multicomponent intervention that includes several techniques (behavioral therapy, bladder training, pelvic muscle training, lifestyle/diet modification, educational sessions on the normal urinary tract system, as well as self-monitoring of urinary habits) improves health-related quality-of-life for women with moderate-to-severe overactive bladder (OAB). These findings suggest that the cognitive component may be an effective treatment option for women with OAB. The study has several limitations: the possibility of overestimating the effects should be noted in the study design; the participants included those taking and not taking OAB medication at baseline and; the multicomponent intervention was conducted by a single expert clinician. Further research in this area and larger clinical trials should be done.
There is a lot of excitement and work being done to manage some of the care via online tools while patients await appointments. It is helpful to see outcome data related to this.
, McMaster University