Fecal IncontinenceNCT01949922
Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
A study testing Injection of autologous muscle fibers into the anal sphincter., Pelvic floor muscle training and Dietary intervention in people with Fecal Incontinence and Anal Incontinence, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Fecal Incontinence, Anal Incontinence
- What is being tested?
- Injection of autologous muscle fibers into the anal sphincter., Pelvic floor muscle training and Dietary intervention
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fecal incontinence
- Wexner score >= 9 or affected quality of life.
- Understanding and speaking danish
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology, Herlev University Hospital
Copenhagen, Herlev, DK-2730
Hanna Jangö, MD, PhD-student, +4538689649, hanna.jango@regionh.dk
Søren Gräs, MD, senior consultant, +4538682361, soeren.gras@regionh.dk
About this study
Official title: 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.
Read more
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
- Being tested
- Injection of autologous muscle fibers into the anal sphincter., Pelvic floor muscle training, Dietary intervention, Analgesia
- Keywords
- regenerative medicine, fecal incontinence, muscle fiber injection
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous muscle fibers into the anal sphincter.Procedure or surgery
Pelvic floor muscle trainingProcedure or surgery
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.
Dietary interventionBehavioural
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.
AnalgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Injection of autologous muscle fibers into the anal sphincter.; Procedure: Pelvic floor muscle training; Behavioral: Dietary intervention; Drug: Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the treatment using fecal incontinence score: Wexner score.
Measured: 1 year
Secondary outcomes (1)
Safety
Number of adverse events, pain etc.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Jangö, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949922
- Sponsor's protocol ID
- H-2-2013-027
- Status last verified
- Feb 2016
- First submitted
- 11 Apr 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.
- ClinicalTrials.gov ID
- NCT01949922
- Acronym / sponsor ID
- H-2-2013-027
- Conditions
- Fecal Incontinence, Anal Incontinence
- Keywords
- regenerative medicine, fecal incontinence, muscle fiber injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of autologous muscle fibers in the anal sphincter | Experimental | Procedure: Injection of autologous muscle fibers into the anal sphincter., Procedure: Pelvic floor muscle training, Behavioral: Dietary intervention, Drug: AnalgesiaAll 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fecal incontinence
- Wexner score >= 9 or affected quality of life.
- Understanding and speaking danish
- Informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of autologous muscle fibers into the anal sphincter. | Procedure or surgery | Injection of autologous muscle fibers in the anal sphincter |
| Pelvic floor muscle trainingPelvic 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. | Procedure or surgery | Injection of autologous muscle fibers in the anal sphincter |
| Dietary interventionDietary 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. | Behavioural | Injection of autologous muscle fibers in the anal sphincter |
| AnalgesiaPatients 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. | Drug | Injection of autologous muscle fibers in the anal sphincter |
Primary outcome
Efficacy of the treatment using fecal incontinence score: Wexner score.
Time frame: 1 year
1 secondary outcome
Safety
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous muscle fibers into the anal sphincter., Pelvic floor muscle training and Dietary intervention in people with Fecal Incontinence and Anal Incontinence, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Jangö, MD, ph.d.-student (+4538689649, hanna.jango@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the treatment using fecal incontinence score: Wexner score. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.