Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter

Study Overview
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Brief Summary
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Aim: To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence. Method: Patients with fecal incontinence after obstetric anal sphincter rupture will be included. After inclusion, they will be offered 3 months of pelvic floor muscle training. If the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. The patients will be followed one year after the injection. The autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. A small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample. The study is a pilot study.

Official Title
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Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.

Conditions
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Fecal Incontinence, Anal Incontinence

Intervention / Treatment
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* Procedure: Injection of autologous muscle fibers into the anal sphincter.
* Procedure: Pelvic floor muscle training
* Behavioral: Dietary intervention
* Drug: Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fecal incontinence Wexner score >= 9 or affected quality of life. Understanding and speaking danish Informed consent Exclusion Criteria: Ongoing pregnancy Delivery in the last 12 months colostomy chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa) improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of autologous muscle fibers in the anal sphincter<br>All patients, that still have relevant symptoms after completion of three months with individualized pelvic floor muscle training and dietary intervention to control defecatory function, will be offered injection of autologous muscle fiber fragments in the anal sphincter. A myscle biopsy will be taken from the leg, cut into small pieces in a saline solution and injected in the anal sphincter. | Procedure: Injection of autologous muscle fibers into the anal sphincter.<br> <br> Procedure: Pelvic floor muscle training<br>* Pelvic floor muscle training 3 months to optimize pelvic floor muscle function. Autologous muscle stem cell injection will only be offered to patients that still have problems after completion of pelvic floor muscle training.<br>Behavioral: Dietary intervention<br>* Dietary intervention 3 months to optimize defecatory function. Autologous muscle stem cell injection will only be offered to patients that still have problems after completion of pelvic floor muscle training and dietary intervention.<br>Drug: Analgesia<br>* Patients will be offered analgesia as needed during and after surgery. Specific products will depend on allergy and preferences of doctors involved and patient's requirements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the treatment using fecal incontinence score: Wexner score. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of adverse events, pain etc. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regenerative medicine, fecal incontinence, muscle fiber injection