None listed
Conditions
Brief summary
When conservative treatment fails for constipation or faecal incontinence, biofeedback and pelvic floor health therapy are two different management options. These two modalities are often thought to be similar by some physicians due to both employing components of pelvic exercise. However, these two modalities have very distinct programmes and are usually delivered by different health care professionals (nurses versus physiotherapists). Despite this, no randomised controlled trial has been performed to date to compare them for both indications. This study aims to investigate any difference in outcome between the two modalities.
Interventions
Pelvic floor health therapy:
Patients in this arm will undergo total of six one-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 gi
Pelvic floor health therapy: Patients in this arm will undergo total of six one-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.
Sponsors
Royal Northshore Hospital - Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed