Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Study Overview
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Brief Summary
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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
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Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Official Title
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Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Anal injection of Nasha Dx


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anal injection of Nasha Dx<br> | Procedure: Anal injection of Nasha Dx<br>* Submucous injection of Nasha Dx 5-10 mm above dentate line<br>* Other names: Solesta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response as measured by a 50% reduction in no of incontinence episodes. |  | One year posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | One year posttreatment | 
| Global assessment | Graded by the patient as excellent, good, fair or poor | One year posttreatment | 
| Change in incontinence episodes | Measured relative baseline based on a 4-week diary | One year posttreatment | 
| Quality of life | Measured with a validated bowel function questionnaire | One year posttreatment | 
| Adverse events |  | Two years posttreatment | 
| Global assessment | Graded by the patient as excellent, good, fair or poor | Two years posttreatment | 
| Change in incontinence episodes | Measured relative baseline based on a 4-week diary | Two years posttreatment | 
| Quality of life | Measured with a validated bowel function questionnaire | Two years posttreatment | 
| Treatment response as measured by a 50% reduction in no of incontinence episodes. |  | Two years posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Treatment, Surgery