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

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Standard

Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence : Statistical analysis plan for a randomised controlled trial. / Ussing, Anja; Dahn, Inge; Due, Ulla; Sørensen, Michael; Petersen, Janne; Bandholm, Thomas.

I: Contemporary Clinical Trials Communications, Bind 8, 2017, s. 192-202.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Ussing, A, Dahn, I, Due, U, Sørensen, M, Petersen, J & Bandholm, T 2017, 'Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial', Contemporary Clinical Trials Communications, bind 8, s. 192-202. https://doi.org/10.1016/j.conctc.2017.07.006

APA

Ussing, A., Dahn, I., Due, U., Sørensen, M., Petersen, J., & Bandholm, T. (2017). Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial. Contemporary Clinical Trials Communications, 8, 192-202. https://doi.org/10.1016/j.conctc.2017.07.006

Vancouver

Ussing A, Dahn I, Due U, Sørensen M, Petersen J, Bandholm T. Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial. Contemporary Clinical Trials Communications. 2017;8:192-202. https://doi.org/10.1016/j.conctc.2017.07.006

Author

Ussing, Anja ; Dahn, Inge ; Due, Ulla ; Sørensen, Michael ; Petersen, Janne ; Bandholm, Thomas. / Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence : Statistical analysis plan for a randomised controlled trial. I: Contemporary Clinical Trials Communications. 2017 ; Bind 8. s. 192-202.

Bibtex

@article{ba1d9b7a492d4c8fb277c3f64b93b113,
title = "Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial",
abstract = "Introduction Faecal 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. Design Randomised, controlled, superiority trial with two parallel arms. Methods 100 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.",
keywords = "Attention-control treatment, Faecal incontinence, Randomized controlled trial, Statistical analysis plan, Strength biofeedback, Supervised pelvic floor muscle training",
author = "Anja Ussing and Inge Dahn and Ulla Due and Michael S{\o}rensen and Janne Petersen and Thomas Bandholm",
year = "2017",
doi = "10.1016/j.conctc.2017.07.006",
language = "English",
volume = "8",
pages = "192--202",
journal = "Contemporary Clinical Trials Communications",
issn = "2451-8654",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence

T2 - Statistical analysis plan for a randomised controlled trial

AU - Ussing, Anja

AU - Dahn, Inge

AU - Due, Ulla

AU - Sørensen, Michael

AU - Petersen, Janne

AU - Bandholm, Thomas

PY - 2017

Y1 - 2017

N2 - Introduction Faecal 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. Design Randomised, controlled, superiority trial with two parallel arms. Methods 100 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.

AB - Introduction Faecal 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. Design Randomised, controlled, superiority trial with two parallel arms. Methods 100 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.

KW - Attention-control treatment

KW - Faecal incontinence

KW - Randomized controlled trial

KW - Statistical analysis plan

KW - Strength biofeedback

KW - Supervised pelvic floor muscle training

U2 - 10.1016/j.conctc.2017.07.006

DO - 10.1016/j.conctc.2017.07.006

M3 - Journal article

C2 - 29696209

AN - SCOPUS:85032008744

VL - 8

SP - 192

EP - 202

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

ER -

ID: 189360198