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

Fecal Incontinence Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

• NCT number: NCT01949922
• Study type: Interventional
• Source: Herlev Hospital
• Contact: Hanna Jangö, MD, ph.d.-student
• Phone: +4538689649
• Email: hanna.jango@regionh.dk
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: January 2018