Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial.
Arch Gynecol Obstet
; 304(5): 1243-1251, 2021 11.
Article
in English
| MEDLINE | ID: covidwho-1366355
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Urinary Incontinence
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Female
/
Humans
Language:
English
Journal:
Arch Gynecol Obstet
Journal subject:
Gynecology
/
Obstetrics
Year:
2021
Document Type:
Article
Affiliation country:
S00404-021-06179-4
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