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Comment
. 2021 Nov;304(5):1243-1251.
doi: 10.1007/s00404-021-06179-4. Epub 2021 Aug 20.

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

Jackie Oldham  1 , Julia Herbert  2 , Jane Garnett  3 , Stephen A Roberts  4
Affiliations
Comment

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

Jackie Oldham et al. Arch Gynecol Obstet. 2021 Nov.

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 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.

Keywords: Electrostimulation device; Female urinary incontinence; Pelvic floor muscle; Randomised Controlled Trial; Rehabilitation.

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Conflict of interest statement

All authors received grant funding from Femeda for the submitted work and declare Jackie Oldham holds the patent for the electrical stimulation regimen incorporated in the Pelviva device. Julia Herbert was the Clinical Director to Femeda and received a consultancy fee from the Company.

Figures

Fig. 1
Fig. 1
Consort diagram—summary of participant flow
Fig. 2
Fig. 2
ICIQ-UI total score (primary outcome) at the two assessment times by treatment arm. Left hand panel shows the actual scores and the right-hand panel the changes from baseline. Boxplots represent the median, inter-quartile range and absolute range. Means per group are shown by points and lines
See this image and copyright information in PMC

Comment on

References

    1. Buckley BS, Lapitan MCM. Prevalence or urinary incontinence in men, women and children current evidence: findings of the fourth international consultation on incontinence. Urology. 2010;76(2):265–270. doi: 10.1016/j.urology.2009.11.078. - DOI - PubMed
    1. Temml C, Haidinger G, Schmidbauer J, Schatzl G, Madersbacher S. Urinary incontinence in both sexes: prevalence rates and impact on quality of life and sexual life. Neurourol Urodyn. 2000;19(3):257–271. doi: 10.1002/(SICI)1520-6777(2000)19:3<259::AID-NAU7>3.0.CO;2-U. - DOI - PubMed
    1. Bo K, Frawley HC, Haylen BT, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for the conservative nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol. 2017;28(2):191–213. doi: 10.1007/s00192-016-3123-4. - DOI - PubMed
    1. Bø K, Larsen S, Oseid S, Kvarstein B, Hagen R, Jorgensen K. Knowledge about and ability to correct pelvic floor muscle exercises in women with stress urinary incontinence. Neurourol Urodyn. 1988;69:261–262.
    1. Bump RC, Hunt WG, Fantl JA, Wyman JF. Assessment of kegel pelvic muscle exercise performance after brief verbal instruction. Am J Obs Gyn. 1991;165:322–329. doi: 10.1016/0002-9378(91)90085-6. - DOI - PubMed

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