Trial reportArchives of gynecology and obstetrics2024
Randomised controlled pilot trial to assess effect of electrical stimulation of weak pelvic floor muscles.
Trial report in Archives of gynecology and obstetrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
Abstract
introduction and hypothesisPelvic floor muscle training (PFMT) has level 1A scientific evidence for the treatment of urinary incontinence and pelvic organ prolapse. Past studies, however, have often excluded women with very weak pelvic floor muscles (PFM). The aim was to investigate the hypothesis that intravaginal electrical stimulation (iES) improves PFM strength more than PFMT in women with weak PFM, and to use these results to calculate sample size required for a future large randomised controlled trial (RCT).
methodsThis assessor-blinded pilot RCT had a two arm, parallel design with computer-generated Randomisation. Both groups were offered 12 one-to-one physiotherapy sessions over a 6-month period. The iES group received individual tailored electrical pulse parameters. The PFMT group received PFM exercises, with the addition of facilitation techniques at therapy sessions. A power calculator was used to calculate sample size.
resultsFifteen women were recruited. Eight were randomised to iES and 7 to PFMT. Two subjects dropped out of the iES group. Median age was 49 years (range 36-77) and parity 2.1 (range 1-3). Both groups showed increases in PFM strength measured by manometery (iES 12.3, SD 12.0 vs PFMT 10.0, SD 8.1) cmH
conclusionThere was no significant difference between the groups in improvements in PFM strength. To detect a difference, we would have required 95 women in each group.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.