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10.1007/s00404-021-06179-4

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34415401!8377701!34415401
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suck abstract from ncbi


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pmid34415401      Arch+Gynecol+Obstet 2021 ; 304 (5): 1243-1251
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  • Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial #MMPMID34415401
  • Oldham J; Herbert J; Garnett J; Roberts SA
  • Arch Gynecol Obstet 2021[Nov]; 304 (5): 1243-1251 PMID34415401show ga
  • 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.
  • |*COVID-19[MESH]
  • |*Urinary Incontinence/therapy[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |SARS-CoV-2[MESH]


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