Markland Alayne D, Goldstein Karen M, Beasley T Mark, Boyd Emily Malone, Zubkoff Lisa, Kelly Ursula A, Burgio Kathryn L, Vaughan Camille P
Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Birmingham, Alabama, and Atlanta, Georgia.
Department of Medicine, University of Alabama at Birmingham, Birmingham.
JAMA Netw Open. 2025 Sep 2;8(9):e2532111. doi: 10.1001/jamanetworkopen.2025.32111.
Initial treatment for urinary incontinence (UI) includes behavioral treatment. However, access to care may be limited.
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.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT04237753.
尿失禁（UI）的初始治疗包括行为治疗。然而，获得治疗的机会可能有限。
比较两种远程方式进行UI行为治疗的有效性，并评估对治疗无反应者进行强化视频问诊的效果。
设计、地点和参与者：这项序贯、多重分配随机临床试验于2020年4月至2023年9月在美国东南部3个退伍军人事务部医疗保健系统中进行。参与者为有UI且能使用电子邮件的非孕女性退伍军人。
远程干预包括（1）一款移动健康UI应用程序（MyHealtheBladder），为期8周，每天进行课程；（2）由训练有素的UI医疗保健专业人员通过退伍军人事务部视频连接进行的单次视频问诊；（3）对8周时UI症状无改善的女性进行随机强化视频问诊。
主要结局是12周时UI症状的变化，通过国际尿失禁咨询问卷-尿失禁简表（ICIQ-UI SF；评分范围为0-21，分数越高表明UI越严重）进行测量，最小临床重要差异为2.52，用于定义8周时的反应状态。还研究了在两个随机分组中对无反应者序贯增加视频强化问诊的结果。主要分析采用意向性分析和符合方案分析。
在286名随机分组的女性退伍军人中（147名接受UI应用程序；139名接受视频问诊），244名（85%）接受了干预。她们的平均（标准差）年龄为53.2（11.3）岁（范围为23-83岁）。在12周时，UI应用程序组的ICIQ-UI SF评分下降了-3.6（95%置信区间，-4.4至-2.8）分，而视频问诊组下降了-2.3（95%置信区间，-3.1至-1.5）分（P = 0.02）。在8周时UI应用程序无反应组（n = 29 [20%]）中，接受强化视频问诊的（n = 12），ICIQ-UI SF评分变化了-1.0（95%置信区间，-2.4至0.4）分，而继续接受UI应用程序治疗的10名UI应用程序无反应者变化了-1.2（95%置信区间，-1.3至3.7）分（P = 0.10）。在视频问诊无反应组（n = 61 [44%]）中，接受强化视频问诊的（n = 23），ICIQ-UI SF评分变化了-0.9（95%置信区间，-2.1至0.3）分，而继续治疗的30名视频问诊无反应者变化了-0.3（95%置信区间，-1.9至1.2）分（P = 0.58）。UI应用程序组的ICIQ-UI SF评分变化在4周时达到最小临床重要差异阈值（2.52分）（-2.9 [95%置信区间，-3.8至-2.0]分），而视频问诊组直到24周才达到该阈值（-3.4 [95%置信区间，-4.2至-2.5]分）。
这项随机临床试验比较了两种远程行为UI治疗方式，并对女性退伍军人进行了随机强化问诊，发现与视频问诊干预相比，UI应用程序干预使UI症状改善得更早，在12周时组间未达到有意义的临床差异。增加强化视频问诊并未进一步改善UI症状。进一步的研究可以扩展这些方式，以扩大行为UI治疗的可及性。
ClinicalTrials.gov标识符：NCT04237753。
