Randomised controlled trial (RCT) of biofeedback in patients with faecal incontinence

A randomised clinical study was designed to compare two exercise regimen and determine the effect of an information session on the subjective rating of the symptoms of faecal incontinence and quality of life

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000258055

Enrollment

Registered

2010-03-29

Start date

2005-01-19

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

A regimen of prescribed rapid exercises (up to 40, 1 second squeezes) and sustained (up to 40, 10 second squeeze) per day for 5 weeks (Session 3, Week 3 to Session 5, Week 8). Session 1 included severity, quality of life, and physiological (manometry) assessment, medical/surgical history and review of bowel chart/food diary. Session 2 included re-assessment of severity and quality of life plus relaxation breathing training.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Faecal incontinence; show some increase in anal sphincter pressure during voluntary squeeze; are able to perceive a distended rectal balloon at a threshold of <150cc; are capable of understanding and cooperating; are willing to participate and consent.

Exclusion criteria

Children (under 18); patients with: gastrointestinal stoma, self reported pregnancy, terminal illness, rectal prolapses, mental illness (by medication type)

Outcome results