Digital Therapeutic Device for Urinary Incontinence: An 18- and 24-month Follow-up of a Randomized Controlled Trial

Objectives: An 8-week randomized controlled trial (RCT) showed that a motion-based digital therapeutic device used to guide PFMT was superior to a home PFMT program for the treatment of stress UI and stress- predominant mixed UI. The objective of this study was to evaluate the long-term impact of the initial 8-week pelvic floor muscle training(PFMT) over 18-months and 24-months. Following the 8-week training period, participants were not specifically asked to continue exercising.

Methods: Between October 2020-March 2021, an all-remote RCT randomized 363 women with stress or stress-dominant mixed UI to complete PFMT using a motion-based prescription digital therapeutic intravaginal device (Axena Health, Inc) (intervention group) or a home program following written/video instructions (control group). Primary outcomes at 8-weeks included the Urogenital Distress Inventory, short-form (UDI-6) and stress UI episodes on a 3-day bladder diary. At 18-and 24-month follow up, UDI-6, Patient Global Impression of Improvement(PGI-I), and adherence data were collected. PGI-I improvement was defined as responses of ‘much better’ or ‘very much better.’ A modified intention-to-treat analysis was performed using Student t-tests and Chi-square tests as appropriate.

Results: Of 299 subjects analyzed at 8-weeks, 228 (76.2%) returned 18-month data, 128 and 100 in the control and intervention groups, respectively. Preliminary 24-month data show 208/274 (76%) of eligible subjects responded (Figure 1). 25 subjects have not yet reached 24-month follow up. There were no demographic or baseline UDI-6 differences between those who did or did not return 18-month data. Mean age was 52.0 ± 12.3 years, and mean BMI was 31.8 ± 7.4 kg/m2; 82% of subjects were parous, and 52% were post-menopausal. Mean change in UDI-6 scores from baseline to 18-months was significantly greater in the intervention group than the control group (-18.96 vs. -13.28 points, P = 0.02), (Table 1). Mean change in UDI-6 scores from baseline to 24 months was significantly greater in the intervention group than the control group based on available data (-20.3 vs.-14.9, p=0.042). Reported improvement using PGI-I was greater in the intervention group than the control group at 6-months (36.4% vs. 21.0%, OR 2.14, (95%CI 1.18, 3.88).

Conclusions: PFMT guided by a motion-based digital therapeutic vaginal device yielded significantly greater continued UI symptom improvement compared to a standard home program. Improved results are durable through 18 months and available 24-months data, even in the absence of active exercise. Use of this technology may provide optimized durable efficacy, facilitating remote access to PFMT with biofeedback for women with UI and represents an effective modality for enhancing conservative first-line care above a standard PFMT home program.


References:

< Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence. Obstetrics & Gynecology. 2022 Apr 1;139(4):606-615. doi:10.1097/aog.000000000000472