Fecal incontinence, grade I and above R15
Conditions
Interventions
Group 1: Contrain (Procon GmbH, 22393 Hamburg, Germany) will be used with rectal sitting electrode. The combination EMG biofeedback plus electrostimulation will be used. Patients will be treated with
Sponsors
Universitätsklinikum Gießen und Marburg GmbH
Sitz Gießen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with fecal incontinence of any cause and at least grade I.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| In all cases, 3 and 6 months, respectively, after randomization, and 3 and 6 months after randomization compared with baseline. 1. Adapted Vaizey score. 2. Quality of life according to Fecal Incontinence Quality of Life Scale (FIQoL) [Rockwood et al. 1999]. 3. Success record. 4. Achievement of individual treatment goals. 5. Stool frequency. 6. Intake of stool-regulating medication. 6. Sub group by sphinkter damages yes/no. 7. Subgroups by neuropathies yes/no. 8. Harninkontinenz. 9. Manometrie. 10. BMI. 11. CCS after 3 months. 12. Stratification by centre. | — |
Countries
Germany
Contacts
Public ContactThilo Schwandner
Klinik für Allgemein-, Viszeral-, Thorax-, Transplantations- und Kinderchirurgie
Outcome results
None listed