Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- Injection of autologous muscle fibers into the anal sphincter.
- Conditions
- Fecal Incontinence
- Sponsor
- Herlev Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Efficacy of the treatment using fecal incontinence score: Wexner score.
- Last Updated
- 10 years ago
Overview
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.
Investigators
Hanna Jangö
MD, PhD-student
Herlev Hospital
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Injection of autologous muscle fibers into the anal sphincter.
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.
Intervention: Pelvic floor muscle training
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.
Intervention: Dietary intervention
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.
Intervention: Analgesia
Outcomes
Primary Outcomes
Efficacy of the treatment using fecal incontinence score: Wexner score.
Time Frame: 1 year
Secondary Outcomes
- Safety(1 year)