Abstract
IMPORTANCE: Initial treatment for urinary incontinence (UI) includes behavioral treatment. However, access to care may be limited. OBJECTIVE: To compare the effectiveness of 2 remote modalities for UI behavioral treatments and to assess the effect of a booster video visit for treatment nonresponders. DESIGN, SETTING, AND PARTICIPANTS: This sequential, multiple assignment randomized clinical trial was conducted in 3 southeastern US Department of Veterans Affairs health care systems from April 2020 through September 2023. Participants were nonpregnant women veterans with UI who had access to email. INTERVENTIONS: Remote interventions included (1) a mobile health UI app (MyHealtheBladder) with daily sessions delivered for 8 weeks or (2) a single video visit through VA Video Connect delivered by trained UI health care professionals and (3) a randomized booster video visit for women without UI symptom improvement at 8 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was change in UI symptoms at 12 weeks as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF; score range, 0-21, with higher scores indicating more severe UI) with a minimal clinically important difference of 2.52 defining response status at 8 weeks. The results of the sequential addition of a video booster visit for nonresponders in both randomization groups were also investigated. Primary analyses were assessed using intention-to-treat and per-protocol analyses. RESULTS: Of 286 women veterans randomized (147 to UI app; 139 to video visit), 244 (85%) received an intervention. Their mean (SD) age was 53.2 (11.3) years (range, 23-83 years). At 12 weeks, ICIQ-UI SF scores for the UI app group decreased -3.6 (95% CI, -4.4 to -2.8) points compared with -2.3 (95% CI, -3.1 to -1.5) points for the video visit group (P = .02). In the UI app nonresponder group at 8 weeks (n = 29 [20%]) with the booster video visit (n = 12), ICIQ-UI SF scores changed -1.0 (95% CI, -2.4 to 0.4) points vs -1.2 (95% CI, -1.3 to 3.7) points for 10 UI app nonresponders who continued UI app treatment (P = .10). In the video visit nonresponder group (n = 61 [44%]) with the booster video visit (n = 23), ICIQ-UI SF scores changed -0.9 (95% CI, -2.1 to 0.3) points vs -0.3 (95% CI, -1.9 to 1.2) points in 30 video visit nonresponders who continued treatment (P = .58). The change in ICIQ-UI SF scores for the UI app reached the MCID threshold (2.52 points) in 4 weeks (-2.9 [95% CI, -3.8 to -2.0] points), whereas the video visit group did not reach this threshold until 24 weeks (-3.4 [95% CI,-4.2 to -2.5] points). CONCLUSIONS AND RELEVANCE: This randomized clinical trial comparing 2 remote delivery modalities of behavioral UI treatment with randomized booster visits among women veterans found that UI symptoms improved earlier for the UI app intervention compared with the video visit intervention, without reaching a meaningful clinical between-group difference at 12 weeks. The addition of a booster video visit did not further improve UI symptoms. Further research could extend these modalities to broaden access to behavioral UI treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04237753.