NCT01949922

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence
• Anal Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-01-01
• Completion: 2018-01-01
• First posted: 2013-09-25
• Last updated: 2016-02-19

Locations

1 site across 1 country: Denmark