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

NCT01949922 | Unknown

• 1 other identifier: H-2-2013-027
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Anal Incontinence

Keywords

regenerative medicine; fecal incontinence; muscle fiber injection

Outcome Measures

Primary Outcomes (1)

• Efficacy of the treatment using fecal incontinence score: Wexner score.

  1 year

Secondary Outcomes (1)

• Safety

  1 year

Other Outcomes (5)

• Improvement of life quality

  1 year

• Improvement of anal sphincter functioning assessed by anal reflectometry

  1 year.

• Improvement of fecal incontinence after pelvic floor muscle training.

  3 months

Study Arms (1)

Injection of autologous muscle fibers in the anal sphincter

EXPERIMENTAL

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.

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

Interventions

Injection of autologous muscle fibers into the anal sphincter. PROCEDURE

Injection of autologous muscle fibers in the anal sphincter

Pelvic floor muscle training PROCEDURE

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.

Injection of autologous muscle fibers in the anal sphincter

Dietary intervention BEHAVIORAL

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.

Injection of autologous muscle fibers in the anal sphincter

Analgesia DRUG

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.

Injection of autologous muscle fibers in the anal sphincter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fecal incontinence
• Wexner score \>= 9 or affected quality of life.
• Understanding and speaking danish
• Informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, Herlev University Hospital

Copenhagen, Herlev, DK-2730, Denmark

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Interventions

Diet Therapy; Analgesia

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Anesthesia and Analgesia

Central Study Contacts

Hanna Jangö, MD, ph.d.-student

CONTACT

+4538689649; hanna.jango@regionh.dk

Søren Gräs, MD, senior consultant

CONTACT

+4538682361; soeren.gras@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: September 25, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

DK (1)