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

Jackie Oldham,Jane Garnett,Stephen A Roberts,Julia Herbert

doi:10.1007/s00404-021-06179-4

Abstract

AimsTo 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).MethodsOpen 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.ResultsPelviva 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 were also observed for PGI-I at both 6 weeks (P = 0.001) and 12 weeks (P < 0.001). In the Pelviva group, 17% of women described themselves as feeling very much better and 54% a little or much better compared to 0% and 15% in the TAU. Overall PISQ-IR score reached statistical significance (P = 0.032) seemingly related to impact (P = 0.027). No other outcome measures reached statistical significance. Premature termination due to COVID-19 meant only 86 women were recruited from a sample size of 264. TAU did not reflect NICE guidelines.ConclusionsThis study suggests Pelviva is more successful than TAU in treating urinary incontinence in Primary Care. The study had reduced power due to early termination due to COVID-19 and suggests TAU does not follow NICE guidelines.

Highlights

Bladder problems affect millions of people worldwide with 25–45% of women reporting some degree of urinary incontinence [1]
COVID-19 pandemic restrictions prevented face-to-face contact at the 12-week follow-up and the pad test could only be completed at baseline
Results of the ICIQ-UI are summarised in Table 2 and Fig. 2

Summary

Introduction

Bladder problems affect millions of people worldwide with 25–45% of women reporting some degree of urinary incontinence [1]. The impact can be considerable and distressing, affecting both quality of life and sexual function [2]. The most common types of incontinence in women are stress, urgency and mixed [3]. Stress urinary incontinence (SUI) is associated with leakage of urine during activities that increase intra-abdominal pressure (physical exertion, coughing, or sneezing). Urgency urinary incontinence (UUI) is associated with urgency, frequency or being woken at night to pass urine. Stress and urgency incontinence together is classified as mixed urinary incontinence (MUI)

Methods

Results

Conclusion