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

Not Applicable

• Conditions: Fecal Incontinence; Anal Incontinence
• Interventions: Procedure: Injection of autologous muscle fibers into the anal sphincter.; Procedure: Pelvic floor muscle training; Behavioral: Dietary intervention; Drug: Analgesia

• Registration Number: NCT01949922
• Lead Sponsor: Herlev Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-25
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection of autologous muscle fibers in the anal sphincter	Dietary intervention	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.
Injection of autologous muscle fibers in the anal sphincter	Injection of autologous muscle fibers into 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.
Injection of autologous muscle fibers in the anal sphincter	Pelvic floor muscle training	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.
Injection of autologous muscle fibers in the anal sphincter	Analgesia	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of the treatment using fecal incontinence score: Wexner score.	1 year

Secondary Outcome Measures

Name	Time	Method
Safety	1 year	Number of adverse events, pain etc.

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, Herlev University Hospital; 🇩🇰 Copenhagen, Herlev, Denmark