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Physiotherapy in Fecal Incontinence Trial

A randomized controlled trial of physiotherapy in patients with fecal incontinence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29012
Enrollment
100
Registered
2007-05-16
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

fecal incontinence, fecale incontinentie, ontlastingsincontinentie

Interventions

Trial arm 1: pelvic floor muscle training and rectal balloon training Trial arm 2: pelvic floor muscle training Both groups receive 12 treatments, each 35 minutes in duration, within three months

Sponsors

Maastricht University University Hospital Maastricht Pelvic care Center Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Vaizey incontinence score

Secondary

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

Contacts

Public ContactEMJ Bols

Maastricht University Department of Epidemiology PO Box 616

EMJ.Bols@epid.unimaas.nl+ 31 43 388 22 53

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)