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dc.contributor.authorOldham, Jackie; orcid: 0000-0001-5857-9551; email: jackie.oldham@manchester.ac.uk
dc.contributor.authorHerbert, Julia
dc.contributor.authorGarnett, Jane
dc.contributor.authorRoberts, Stephen A.
dc.date.accessioned2021-10-04T15:23:43Z
dc.date.available2021-10-04T15:23:43Z
dc.date.issued2021-08-20
dc.date.submitted2021-05-27
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/626028/404_2021_Article_6179_nlm.xml?sequence=2
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/626028/404_2021_Article_6179.pdf?sequence=3
dc.identifier.citationArchives of Gynecology and Obstetrics, volume 304, issue 5, page 1243-1251
dc.identifier.urihttp://hdl.handle.net/10034/626028
dc.descriptionFrom Springer Nature via Jisc Publications Router
dc.descriptionHistory: 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
dc.descriptionPublication status: Published
dc.descriptionFunder: Femeda
dc.description.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.
dc.languageen
dc.publisherSpringer Berlin Heidelberg
dc.rightsLicence for this article: http://creativecommons.org/licenses/by/4.0/
dc.sourcepissn: 0932-0067
dc.sourceeissn: 1432-0711
dc.subjectGeneral Gynecology
dc.subjectElectrostimulation device
dc.subjectFemale urinary incontinence
dc.subjectPelvic floor muscle
dc.subjectRandomised Controlled Trial
dc.subjectRehabilitation
dc.titleEffects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial
dc.typearticle
dc.date.updated2021-10-04T15:23:43Z
dc.date.accepted2021-08-04


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