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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Hanna Jangö, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01949922
First received: April 11, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Fecal Incontinence
Anal Incontinence
Procedure: Injection of autologous muscle fibers into the anal sphincter.
Procedure: Pelvic floor muscle training
Behavioral: Dietary intervention
Drug: Analgesia

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Efficacy of the treatment using fecal incontinence score: Wexner score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of adverse events, pain etc.


Other Outcome Measures:
  • Improvement of life quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement of anal sphincter functioning assessed by anal reflectometry [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
  • Improvement of fecal incontinence after pelvic floor muscle training. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement of the anal sphincter by 3D ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between the tissue samples regenerative potential and effect of treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949922

Contacts
Contact: Hanna Jangö, MD, ph.d.-student +4538689649 hanna.jango@regionh.dk
Contact: Søren Gräs, MD, senior consultant +4538682361 soeren.gras@regionh.dk

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

No publications provided

Responsible Party: Hanna Jangö, MD, PhD-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01949922     History of Changes
Other Study ID Numbers: H-2-2013-027
Study First Received: April 11, 2013
Last Updated: September 20, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Herlev Hospital:
regenerative medicine
fecal incontinence
muscle fiber injection

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014