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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01949922
• Other study ID #: H-2-2013-027
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2013
• Last updated: February 18, 2016
• Start date: April 2013
• Est. completion date: January 2018

Study information

• Verified date: February 2016
• Source: Herlev Hospital
• Contact: Hanna Jangö, MD, ph.d.-student
• Phone: +4538689649
• Email: hanna.jango[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

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

• 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.

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynaecology, Herlev University Hospital	Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement of life quality		1 year	No
Other	Improvement of anal sphincter functioning assessed by anal reflectometry		1 year.	No
Other	Improvement of fecal incontinence after pelvic floor muscle training.		3 months	No
Other	Improvement of the anal sphincter by 3D ultrasound.		1 year	No
Other	Correlation between the tissue samples regenerative potential and effect of treatment.		1 year	No
Primary	Efficacy of the treatment using fecal incontinence score: Wexner score.		1 year	No
Secondary	Safety	Number of adverse events, pain etc.	1 year	Yes