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

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev Hospital

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.