Conservative treatment of fecal incontinence: Triple target treatment versus low frequent electrostimulatio

Not Applicable

• Conditions: Fecal incontinence, grade I and above; R15; Faecal incontinence

• Registration Number: DRKS00000138
• Lead Sponsor: niversitätsklinikum Gießen und Marburg GmbHSitz Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Study Completion: 2010-12-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with fecal incontinence of any cause and at least grade I.

Exclusion Criteria

Patients with retention-overflow incontinence, rectal prolapse grade III, chronic inflammatory bowel diseases, will be excluded, as well as patients who are mentally or intellectually incapable of independent training. Further exclusion criteria are age under 18 years, and definite or possible pregnancy.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary endpoint is based on the Cleveland Clinic Score (CCS) in its validated German version. Primary endpoint is the difference of the CCS (continent 0, incontinent 20) between baseline and six month after randomization.

Secondary Outcome Measures

Name	Time	Method
In all cases, 3 and 6 months, respectively, after randomization, and 3 and 6 months after randomization compared with baseline.<br>1. Adapted Vaizey score.<br>2. Quality of life according to Fecal Incontinence Quality of Life Scale (FIQoL) [Rockwood et al. 1999].<br>3. Success record.<br>4. Achievement of individual treatment goals.<br>5. Stool frequency.<br>6. Intake of stool-regulating medication.<br>6. Sub group by sphinkter damages yes/no.<br>7. Subgroups by neuropathies yes/no.<br>8. Harninkontinenz.<br>9. Manometrie.<br>10. BMI.<br>11. CCS after 3 months.<br>12. Stratification by centre.