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A randomized controlled trial of physiotherapy in patients with fecal incontinence

A randomized controlled trial of physiotherapy in patients with fecal incontinence - PhysioFIT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31614
Enrollment
100
Registered
2006-07-20
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

bowel incontinence fecal incontinence

Interventions

Physiotherapeutic treatment is administered according to a standardized protocol, which has been developed by clinicians and physiotherapists specialized in the field of pelvic floor disorders. Phys

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary study outcome is the Vaizey incontinence score. Deze score reflects the severity of FI and ranges from 0 (complete continence) to 24 (complete incontinence).

Secondary

MeasureTime frame
Secondary outcome measures are medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, symptom diary, Fecal Incontinence Quality of Life scale (FIQL), PREFAB-score (severity score) and the Global Perceived Effect score (GPE-score).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)