Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Phase 1
Completed
- Conditions
- Fecal Incontinence
- Interventions
- Procedure: Anal injection of Nasha Dx
- Registration Number
- NCT01380132
- Lead Sponsor
- Uppsala University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 35
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anal injection of Nasha Dx Anal injection of Nasha Dx -
- Primary Outcome Measures
Name Time Method Treatment response as measured by a 50% reduction in no of incontinence episodes. One year posttreatment
- Secondary Outcome Measures
Name Time Method Global assessment Two years posttreatment Graded by the patient as excellent, good, fair or poor
Change in incontinence episodes Two years posttreatment Measured relative baseline based on a 4-week diary
Quality of life Two years posttreatment Measured with a validated bowel function questionnaire
Adverse events Two years posttreatment Treatment response as measured by a 50% reduction in no of incontinence episodes. Two years posttreatment
Trial Locations
- Locations (1)
Department of Surgery, University Hospital
🇸🇪751 82 Uppsala, Sweden