Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial.

ABSTRACT:

Aims

To compare current General Medical Practitioner treatment as usual (TAU) for the treatment of female urinary incontinence with a novel disposable home electro-stimulation device (Pelviva).

Methods

Open label, Primary Care post-market evaluation. 86 women with urinary incontinence were randomly assigned to one of two 12-week treatments: TAU or Pelviva for 30 min every other day plus TAU. Outcome measures included ICIQ-UI (primary), PISQ-IR, PGI-S / PGI-I and FSFI (secondary) at recruitment and immediately after intervention, 1-h pad test at recruitment and usage diaries throughout.

Results

Pelviva plus TAU produced significantly better outcome than TAU alone: 3 versus 1 point for ICIQ-UI (Difference - 1.8 95% CI: - 3.5 to - 0.1, P = 0.033). Significant differences

SUBMITTER: Oldham J 

PROVIDER: S-EPMC8377701 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature