Randomised controlled trial of the efficacy of biofeedback versus pelvic floor physiotherapy in patients with faecal incontinence and constipation.

Not Applicable

Recruiting

• Conditions: Constipation; Faecal incontinence; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12622001516774
• Lead Sponsor: Royal Northshore Hospital - Northern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-06
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1) Patients diagnosed with constipation or faecal incontinence by referring doctor (specialist) AND has been assessed suitable for biofeedback based on the anorectal manometry and clinical profile
2) Age 20 years and above
3) Female
4) Able to speak English
5) Willingness to answer screening questionnaire
6) Willingness to give written informed consent
7) Willingness to comply with the study

Exclusion Criteria

1) Pregnant or currently breastfeeding
2) History of a significant anorectal or distal colon surgery or radiotherapy
3) Significant rectal prolapse
4) Has a nerve stimulator for continence or gastrointestinal motility
5) Had a full course of pelvic floor health physiotherapy within last two years
6) Inability to understand and follow the procedure due to language barrier or underlying medical/mental conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bowel satisfaction score(Visual analogue scale) change[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)];Physician assessed post-treatment progress - Physician impression of patient's progress/changes based on symptoms and physiology as measured on anorectal manometry[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)]

Secondary Outcome Measures

Name	Time	Method
Primary outcome (Constipation arm): Constipation score change<br>[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)];Primary outcome (Faecal incontinence arm) :<br>Faecal incontinence severity index(FISI) change[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)]; Changes in anorectal physiology as measured by manometry and balloon expulsion test pre-and post-treatment[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)];Feeling of control over bowel function using patient reported visual analogue scale[ At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)]