Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence.
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.
|Fecal Incontinence Anal Incontinence||Procedure: Injection of autologous muscle fibers into the anal sphincter. Procedure: Pelvic floor muscle training Behavioral: Dietary intervention Drug: Analgesia|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.|
- Efficacy of the treatment using fecal incontinence score: Wexner score. [ Time Frame: 1 year ]
- Safety [ Time Frame: 1 year ]Number of adverse events, pain etc.
- Improvement of life quality [ Time Frame: 1 year ]
- Improvement of anal sphincter functioning assessed by anal reflectometry [ Time Frame: 1 year. ]
- Improvement of fecal incontinence after pelvic floor muscle training. [ Time Frame: 3 months ]
- Improvement of the anal sphincter by 3D ultrasound. [ Time Frame: 1 year ]
- Correlation between the tissue samples regenerative potential and effect of treatment. [ Time Frame: 1 year ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949922
|Contact: Hanna Jangö, MD, firstname.lastname@example.org|
|Contact: Søren Gräs, MD, senior email@example.com|
|Department of Obstetrics and Gynaecology, Herlev University Hospital||Recruiting|
|Copenhagen, Herlev, Denmark, DK-2730|
|Contact: Hanna Jangö, MD, PhD-student +4538689649 firstname.lastname@example.org|
|Contact: Søren Gräs, MD, senior consultant +4538682361 email@example.com|
|Principal Investigator: Hanna Jangö, MD|
|Sub-Investigator: Søren Gräs, MD|
|Sub-Investigator: Gunnar Lose, Prof, DMSc|
|Sub-Investigator: Niels Klarskov, DMSc, MD|