Anal Incontinence, Fecal Incontinence
Conditions
Keywords
regenerative medicine, fecal incontinence, muscle fiber injection
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.
Interventions
PROCEDUREInjection of autologous muscle fibers into the anal sphincter.
PROCEDUREPelvic 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.
BEHAVIORALDietary 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.
DRUGAnalgesia
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.
Sponsors
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the treatment using fecal incontinence score: Wexner score. | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 year | Number of adverse events, pain etc. |
Other
| Measure | Time frame |
|---|---|
| Improvement of fecal incontinence after pelvic floor muscle training. | 3 months |
| Improvement of life quality | 1 year |
| Correlation between the tissue samples regenerative potential and effect of treatment. | 1 year |
| Improvement of the anal sphincter by 3D ultrasound. | 1 year |
| Improvement of anal sphincter functioning assessed by anal reflectometry | 1 year. |
Countries
Denmark
Contacts
Primary ContactHanna Jangö, MD, ph.d.-student
Backup ContactSøren Gräs, MD, senior consultant
Outcome results
None listed