Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Treatment, Surgery
Brief summary
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
Detailed description
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
Interventions
PROCEDUREAnal injection of Nasha Dx
Submucous injection of Nasha Dx 5-10 mm above dentate line
Sponsors
Galderma R&D
Uppsala University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12). * Age 18-80 * Available for follow-up for the duration of the study * Written informed consent.
Exclusion criteria
* Sphincter defect visible on anal ultrasound. * Pregnancy. * Rectal prolapse or inflammatory bowel disease. * Recent (within 6 months) anal surgery except for haemorrhoids. * Anorectal sepsis. * Anticoagulant medication or bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response as measured by a 50% reduction in no of incontinence episodes. | One year posttreatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | One year posttreatment | — |
| Global assessment | One year posttreatment | Graded by the patient as excellent, good, fair or poor |
| Change in incontinence episodes | One year posttreatment | Measured relative baseline based on a 4-week diary |
| Quality of life | One year posttreatment | Measured with a validated bowel function questionnaire |
| Treatment response as measured by a 50% reduction in no of incontinence episodes. | Two years posttreatment | — |
Countries
Sweden
Outcome results
None listed