Fecal incontinence in female and male patients
Conditions
Brief summary
Changes in frequency of incontinence episodes as measured by the bowel diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92), in both treatment groups.
Detailed description
Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by ≥ 50% under treatment. Derived from diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92).
Interventions
DRUGPLACEBO
DRUGICEF15
Sponsors
Innovacell GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in frequency of incontinence episodes as measured by the bowel diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92), in both treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by ≥ 50% under treatment. Derived from diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92). | — |
Countries
Austria, Bulgaria, Czechia, France, Germany, Italy, Poland, Slovenia, Spain, Sweden
Outcome results
None listed