Evidence map›Paper›PMID 29696209›Full record

ArticleContemporary clinical trials communications2017

Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial.

Anja Ussing, Inge Dahn, Ulla Due, Michael Sørensen, Janne Petersen, Thomas Bandholm

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Anja UssingDepartment of Physiotherapy-and Occupational Therapy, Copenhagen University Hospital, Hvidovre, Kettegaards Allé 30, DK-2650 Hvidovre, Denmark.
Inge DahnDepartment of Surgical and Medical Gastroenterology, Copenhagen University Hospital, Hvidovre, Kettegaards Allé 30, DK-2650 Hvidovre, Denmark.
Ulla DueDepartment of Obstetrics and Gynaecology, Herlev Hospital, Herlev Ringvej 75, DK-2730 Herlev, Denmark.
Michael SørensenDepartment of Surgical and Medical Gastroenterology, Copenhagen University Hospital, Hvidovre, Kettegaards Allé 30, DK-2650 Hvidovre, Denmark.
Janne PetersenOptimed, Clinical Research Center, Copenhagen University Hospital, Hvidovre, Kettegaards Allé 30, DK-2650 Hvidovre, Denmark.
Thomas BandholmDepartment of Physiotherapy-and Occupational Therapy, Copenhagen University Hospital, Hvidovre, Kettegaards Allé 30, DK-2650 Hvidovre, Denmark.
Hvidovre Hospital · DKHerlev Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFaecal incontinence affects approximately 8-9% of the adult population. The condition is surrounded by taboo; it can have a devastating impact on quality of life and lead to major limitations in daily life. Pelvic floor muscle training in combination with information and fibre supplements is recommended as first-line treatment for faecal incontinence. Despite this, the effect of pelvic floor muscle training for faecal incontinence is unclear. No previous trials have investigated the efficacy of supervised pelvic floor muscle training in combination with conservative treatment and compared this to an attention-control massage treatment including conservative treatment. The aim of this trial is to investigate if 16 weeks of supervised pelvic floor muscle training in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in patients with faecal incontinence.

designRandomised, controlled, superiority trial with two parallel arms.

methods100 participants with faecal incontinence will be randomised to either (1) individually supervised pelvic floor muscle training and conservative treatment or (2) attention-control massage treatment and conservative treatment. The primary outcome is participants' rating of symptom changes after 16 weeks of treatment using the Patient Global Impression of Improvement Scale. Secondary outcomes are the Vaizey Incontinence Score, the Fecal Incontinence Severity Index, the Fecal Incontinence Quality of Life Scale, a 14-day bowel diary, anorectal manometry and rectal capacity measurements. Follow-up assessment at 36 months will be conducted. DISCUSSION: This paper describes and discusses the rationale, the methods and in particular the statistical analysis plan of this trial.

Indexed as

Attention-control treatmentCONSORT, Consolidated Standards of Reporting TrialsEMG, electromyographyFaecal incontinenceFIQL, Fecal Incontinence Quality of Life ScaleFISI, Fecal Incontinence Severity IndexPFMT, Pelvic floor muscle trainingPGI-I, Patient Global Impression of Improvement ScaleRandomized controlled trialSPIRIT, Standard Protocol Items: Recommendation for Interventional TrialsStatistical analysis planStrength biofeedbackSupervised pelvic floor muscle trainingTIDieR, Template for Intervention Description and Replication

Identifiers

PMID29696209
PMCPMC5898528
OpenAlexW2739222794

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.