Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial
| Autor: | Ulla Due, Michael Sørensen, Anja Ussing, Inge Dahn, Thomas Bandholm, Janne Petersen |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Statistical analysis plan
medicine.medical_specialty Strength biofeedback FISI Fecal Incontinence Severity Index Electromyography Pelvic Floor Muscle Article law.invention 03 medical and health sciences 0302 clinical medicine Superiority Trial Physical medicine and rehabilitation Randomized controlled trial Quality of life law FIQL Fecal Incontinence Quality of Life Scale medicine Fecal incontinence 030212 general & internal medicine SPIRIT Standard Protocol Items: Recommendation for Interventional Trials TIDieR Template for Intervention Description and Replication Pharmacology lcsh:R5-920 Massage medicine.diagnostic_test business.industry Anorectal manometry Faecal incontinence Attention-control treatment General Medicine Supervised pelvic floor muscle training PFMT Pelvic floor muscle training PGI-I Patient Global Impression of Improvement Scale Physical therapy 030211 gastroenterology & hepatology medicine.symptom lcsh:Medicine (General) business CONSORT Consolidated Standards of Reporting Trials EMG electromyography |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 8, Iss C, Pp 192-202 (2017) 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, vol. 8, pp. 192-202 . https://doi.org/10.1016/j.conctc.2017.07.006 |
| ISSN: | 2451-8654 |
| DOI: | 10.1016/j.conctc.2017.07.006 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|