We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified February 2016 by Hanna Jangö, Herlev Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01949922
First Posted: September 25, 2013
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanna Jangö, Herlev Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Hanna Jangö, Herlev Hospital:

Primary Outcome Measures:
  • Efficacy of the treatment using fecal incontinence score: Wexner score. [ Time Frame: 1 year ]

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


Other Outcome Measures:
  • Improvement of life quality [ Time Frame: 1 year ]
  • Improvement of anal sphincter functioning assessed by anal reflectometry [ Time Frame: 1 year. ]
  • Improvement of fecal incontinence after pelvic floor muscle training. [ Time Frame: 3 months ]
  • Improvement of the anal sphincter by 3D ultrasound. [ Time Frame: 1 year ]
  • Correlation between the tissue samples regenerative potential and effect of treatment. [ Time Frame: 1 year ]

Estimated Enrollment: 15
Study Start Date: April 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hanna Jangö, MD, PhD-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01949922     History of Changes
Other Study ID Numbers: H-2-2013-027
First Submitted: April 11, 2013
First Posted: September 25, 2013
Last Update Posted: February 19, 2016
Last Verified: February 2016

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

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