Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial
AuthorsOldham, Jackie; orcid: 0000-0001-5857-9551; email: email@example.com
Roberts, Stephen A.
MetadataShow full item record
AbstractAbstract: 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 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. Conclusions: This 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.
CitationArchives of Gynecology and Obstetrics, volume 304, issue 5, page 1243-1251
PublisherSpringer Berlin Heidelberg
DescriptionFrom Springer Nature via Jisc Publications Router
History: received 2021-05-27, accepted 2021-08-04, registration 2021-08-05, pub-electronic 2021-08-20, online 2021-08-20, pub-print 2021-11
Publication status: Published