Physiotherapy in Fecal Incontinence Trial

Recruiting

• Conditions: fecal incontinence, fecale incontinentie, ontlastingsincontinentie

• Registration Number: NL-OMON29012
• Lead Sponsor: Maastricht UniversityUniversity Hospital MaastrichtPelvic care Center Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Adults (aged 18 years and older);
2. FI complaints due to different etiologies persisting for at least six months;
3. Vaizey incontinence score of at least 12;
4. Failure of conservative treatment (including dietary adaptations and pharmacological agents)

Exclusion Criteria

1. Patients diagnosed with an anorectal tumor within the past two years;
2. Absent squeeze pressure of anal sphincter;
3. Chronic diarrhea (always fluid stool three or more times a day);
4. Overflow incontinence;
5. Proctitis;
6. Colitis ulcerosa;
7. Crohn's disease;
8. Soiling (defined as leakage of a minimal amount of feces out of the anal canal);
9. Previous ileo-anal or colo-anal anastomosis and/or rectal prolapse in situ are excluded.
10. Participants who received physiotherapy during the previous six months or who are intellectually and/or linguistically incapable to understand therapy are excluded as well.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaizey incontinence score

Secondary Outcome Measures

Name	Time	Method
1. Anorectal resting and squeeze pressure;<br>2. Rectal capacity measurements;<br>3. Anorectal sensation;<br>4. Three-weekdiary results;<br>5. Fecal Incontinence Quality of Life scale;<br>6. PREFAB-score (adapted PRAFAB-score); 7. Global Perceived Effect (GPE-score).