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

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Pelvic floor health therapy: Patients in this arm will undergo total of si Xone‐to‐one sessions occurring every 1‐2 weeks (6‐12 weeks). ‐ each session will be guided by a physiotherapist and up to 60 minutes long. ‐Patients will be prescribed individualised exercises based on each patient’s presenting condition, pattern of their symptoms and clinical assessment of pelvic floor function. ‐Patients will be guided through a series of pelvic floor exercises during the session and will also be given at‐home exercises. ‐Some examples include contraction and relaxation of pelvic floor muscles in different positions and abdomen strengthening exercises. At home exercise will be similar but at much shorter duration. Home exercises may be prescribed daily or multiple times a day. ‐For sessions with physiotherapists, exercises may be assisted by an anal pressure probe or electrical stimulation if it is deemed helpful by the treating physiotherapist. Attendance and progress will be recorded on clinical research database. CONDITION: Constipation;Faecal incontinence; ; Constipation ; Faecal incontinence Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: 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: 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)] Primary outcome (Constipation arm): Constipation score change ; [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) : ; 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)] INCLUSION CRITERIA: 1) Patient diagnosed with constipation or faecal incontinence by referring doctor(specialist) 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
Epistemonikos ID: ec560a530c72f4f646dd0f375dd4e95158462bcc
First added on: Aug 26, 2024