A randomized controlled trial of physiotherapy in patients with fecal incontinence

Phase 3

Completed

• Conditions: bowel incontinence; fecal incontinence; 10017977

• Registration Number: NL-OMON31614
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Adults (aged 18 and over)
Fecal incontinence complaints due to different etiologies persisting for at least 6 months
Vaizey incontinence score of at least 12
Failure of conservative treatment (dietary adaptations and pharmacological agents)

Exclusion Criteria

Physiothery during previous six months
Intelectually or linguistically incapable to finish therapy
Anorectal tumor within past two years
Chronic diarrhea
Overflow incontinence
Proctitis
Colitis ulcerosa
Croh's disease
Soiling
Ileo-anal or colo-anal anastomosis
Rectal prolapse in situ

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcome is the Vaizey incontinence score. Deze score reflects the<br /><br>severity of FI and ranges from 0 (complete continence) to 24 (complete<br /><br>incontinence).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are medication use, anorectal manometry, rectal<br /><br>capacity measurement, anorectal sensation, symptom diary, Fecal Incontinence<br /><br>Quality of Life scale (FIQL), PREFAB-score (severity score) and the Global<br /><br>Perceived Effect score (GPE-score). </p><br>