Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

Digital therapeutic device for urinary incontinence: a randomized controlled trial
Weinstein MM, Dunivan G, Guaderrama NM, Richter HE
Obstetrics and Gynecology 2022 Apr;139(4):606-615
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI). METHODS: In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n = 278) was planned to meet the power analysis requirements for the UDI-6 score (n = 278) and the bladder diary (n = 78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting. RESULTS: From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 versus 14.7, p = 0.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3 to 8) and 5 (3 to 8) episodes to 1 (0 to 3) and 2 (1 to 4) (p = 0.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 (44.1% versus 45/156 (28.8%), odds ratio 1.94, 95% CI 1.21 to 3.15). There were no device-related severe adverse events. CONCLUSION: In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. FUNDING SOURCE: Renovia Inc.
With permission from Excerpta Medica Inc.

Full text (sometimes free) may be available at these link(s):      help