Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Injection of autologous muscle fibers in the anal sphincter 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.
Procedure: Pelvic floor muscle training
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.
Behavioral: Dietary intervention
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.
Drug: Analgesia
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.
|
Outcome Measures
Primary Outcome Measures
- Efficacy of the treatment using fecal incontinence score: Wexner score. [1 year]
Secondary Outcome Measures
- Safety [1 year]
Number of adverse events, pain etc.
Other Outcome Measures
- Improvement of life quality [1 year]
- Improvement of anal sphincter functioning assessed by anal reflectometry [1 year.]
- Improvement of fecal incontinence after pelvic floor muscle training. [3 months]
- Improvement of the anal sphincter by 3D ultrasound. [1 year]
- Correlation between the tissue samples regenerative potential and effect of treatment. [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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fecal incontinence
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Wexner score >= 9 or affected quality of life.
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Understanding and speaking danish
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Informed consent
Exclusion Criteria:
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Ongoing pregnancy
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Delivery in the last 12 months
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colostomy
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chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa)
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improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynaecology, Herlev University Hospital | Copenhagen | Herlev | Denmark | DK-2730 |
Sponsors and Collaborators
- Herlev Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-2-2013-027