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

Herlev Hospital

Status: Unknown

Conditions: Anal Incontinence; Fecal Incontinence

Treatments: Procedure: Pelvic floor muscle training; Procedure: Injection of autologous muscle fibers into the anal sphincter.; Drug: Analgesia; Behavioral: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01949922

H-2-2013-027

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Injection of autologous muscle fibers in the anal sphincter

Experimental group

Description:

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.

Treatment:

Procedure: Injection of autologous muscle fibers into the anal sphincter.

Procedure: Pelvic floor muscle training

Behavioral: Dietary intervention

Drug: Analgesia