Feasibility and short-term comparative outcomes of a digital-assisted community-based electrical stimulation...

This study aimed to assess the feasibility and short-term comparative outcomes of a community-based BES rehabilitation program assisted by a digital service package for postmenopausal women with PFD, and to explore whether pelvic floor muscle strength outcomes were compatible with a prespecified exploratory margin compared with tertiary hospital care.

We conducted a non-randomized controlled study involving 200 community-dwelling postmenopausal women with PFD. Participants in the intervention group received community-based BES plus a digital service package, while contemporaneous controls received standard BES care at a tertiary hospital. Follow-up lasted 1 month. Because treatment allocation was non-randomized, doubly robust estimation and multivariable regression were used to reduce measured confounding; findings should therefore be interpreted as exploratory rather than causal.

The observed rate differences in improvement of Type I and Type II pelvic floor muscle strength were 0.008 and 0.054, respectively. The lower bounds of the 98.75% confidence intervals remained above the prespecified exploratory margin of - 0.20, suggesting that the observed differences were compatible with the prespecified exploratory margin in this exploratory analysis. While no significant between-group difference was found for self-perceived symptom severity, the intervention group was associated with higher self-reported adherence (β = 4.604, P < 0.001), health knowledge awareness (β = 24.419, P < 0.001), and quality of life (OR = 5.292, P = 0.023). Feasibility metrics were favorable, with a mean System Usability Scale score of 81.40. However, given the non-randomized design and the prespecified margin, these findings should be interpreted cautiously.

This pragmatic, digital-assisted community-based rehabilitation program appears feasible and was associated with favorable short-term outcomes in postmenopausal women with PFD. Compared with tertiary hospital care, the integrated community-based program showed pelvic floor muscle strength outcomes that were compatible with the prespecified exploratory margin, while also being associated with higher self-reported adherence, health knowledge, and quality of life. However, because of the non-randomized design, retrospective registration, short follow-up, and potential residual confounding, these findings should be considered preliminary and hypothesis-generating rather than confirmatory evidence of non-inferiority, equivalence, or causal effects.

Chinese Clinical Trial Registry (ChiCTR2400088675); Registered on 23 August 2024, retrospectively registered.