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Randomized Controlled Trial
. 2023 Jan 1;141(1):199-206.
doi: 10.1097/AOG.0000000000005036. Epub 2022 Nov 30.

Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months

Milena M Weinstein  1 , Gena C Dunivan, Noelani M Guaderrama, Holly E Richter
Affiliations
Randomized Controlled Trial

Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months

Milena M Weinstein et al. Obstet Gynecol. .

Abstract

Objective: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI).

Methods: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better" and "very much better" responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate.

Results: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P=.03 and 22.7±23.3 vs 15.9±20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49-4.00).

Conclusion: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care.

Funding source: Renovia Inc.

Clinical trial registration: ClinicalTrials.gov, NCT04508153.

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Conflict of interest statement

Financial Disclosure Milena Weinstein disclosed receiving royalties from UpToDate. Gena C. Dunivan disclosed that money was paid to her institution from Viveve. Holly E. Richter disclosed the following: ongoing research funding: NIH, NIA/UTSouthwestern, NIH, NINR/Univ of Minnesota, NIH, NICHD/UAB, NIH, NIDDK/UNC, PCORI/Brown University, PCORI Dartmouth, Renovia/UAB, EBT Medical/UAB, Reia/UAB Past: Pelvalon, Allergan, Renovia, NICHD, NIDDK. Other disclosures: DSMB Member: BlueWind Medical; UpToDate: Royalties, Board Of Directors: AUGS and WorldWide Fistula Fund; Editorial Duties: IUJO and Obstetrics & Gynecology. The other author did not report any potential conflicts of interest.

References

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