NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation

Study Overview
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Brief Summary
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Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy. The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.

Official Title
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NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation

Conditions
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Fecal Incontinence, Anorectal Malformation

Intervention / Treatment
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* Device: NASHA/Dx (Solesta®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent FI (Miller incontinence score >5) Anorectal malformation. Exclusion Criteria: Pregnancy Rectal prolapse Significant mucosal prolapse Inflammatory bowel disease Anorectal surgery within the last year Before inclusion Anticoagulant medication/bleeding diathesis Anorectal sepsis in the past Immunodeficiency Immunosuppressing therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Interventional Model Description: Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Patients are given NASHA/Dx as a perianal injection | Device: NASHA/Dx (Solesta®)<br>* Perianal submucosal injection of 3-4 ml of NASHA/Dx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of incontinence episodes | The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period. | The change in number of incontinence episodes before treatment is compared with data at 18 months after injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miller´s incontinence score | Change of Miller´s incontinence score | Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence). | 
| Quality of life, general | Change in quality of Life as observed with SF-36 | Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated. | 
| Adverse events | Control of any adverse events during the course of the study | Before treatment compared with data at 18 months after treatment | 
| Quality of life, disease specific | Change in quality of Life as observed with FIQL | Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Anorectal malformation