Randomized Control Trial of Biofeedback Guided Pelvic Floor Exercises in the Treatment in Faecal Incontinence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000747628

Enrollment

351

Registered

2005-11-16

Start date

2006-05-01

Completion date

2012-12-31

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with faecal incontinence may be treated by pelvic floor exercises enhanced with real time feedback using trans-rectal ultrasound and mannometry. This clinical trial will compare three different treatment protocols; standard monthly clinic sessions; initial clinic assessment and treatment session followed by monthly telephone follow-up; assessment and single clinic treatment session only.

Interventions

Telephone support - Assessment and one biofeedback session (using real time rectal ultrasound and mannometry) with four monthly telephone treatment sessions; or Single treatment session only.

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

1) prior assessment by a doctor, nurse specialist or physiotherapist 2) faecal incontinence.

Exclusion criteria

1) complete external sphincter defect, 2) obstructive defecation or constipation 3) defunctioning stoma, 4) currently active inflammatory bowel disease 5) acute perianal inflammation, 6) a potentially reversible cause of incontinence such as acute diarrhoea 7) untreated full-thickness rectal prolapse.

Outcome results