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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev
    • Copenhagen, Herlev, Denmark, DK-2730
      • Recruiting
      • Department of Obstetrics and Gynaecology, Herlev University Hospital
      • Contact: Søren Gräs, MD, senior consultant; Phone Number: +4538682361; Email: soeren.gras@regionh.dk
      • Contact: Hanna Jangö, MD, PhD-student; Phone Number: +4538689649; Email: hanna.jango@regionh.dk
      • Principal Investigator: Hanna Jangö, MD
      • Sub-Investigator: Søren Gräs, MD
      • Sub-Investigator: Gunnar Lose, Prof, DMSc
      • Sub-Investigator: Niels Klarskov, DMSc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Injection of autologous muscle fibers in 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of the treatment using fecal incontinence score: Wexner score.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Number of adverse events, pain etc.	1 year

Other Outcome Measures

Outcome Measure	Time Frame
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
Improvement of the anal sphincter by 3D ultrasound.	1 year
Correlation between the tissue samples regenerative potential and effect of treatment.	1 year

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: regenerative medicine; fecal incontinence; muscle fiber injection
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: H-2-2013-027