Fecal IncontinenceMOS STICNCT01920607
Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence
A study testing magnetic anal sphincter and sacral nerve stimulation in people with Fecal Incontinence and Anal Incontinence, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Incontinence, Anal Incontinence
- What is being tested?
- magnetic anal sphincter and sacral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Aug 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (male or female) of 18 to 75 years of age
- Affected by severe anal incontinence (SAI)*.
- Documented failure of conservative treatment (reeducation and medical treatment)
- With functional anal sphincter**
- Agrees to take part in the study and has signed the informed consent form
- Agrees to undergo post-operative surveillance for a period of one (1) year
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- Covered by National Insurance
- Defined as follows: at least one involuntary passing of stool per week measured by collecting data on incontinence accidents on a 3-week stool record chart, with the continence problem developing over more than 6 months. **Defined as follows: external sphincter intact (without injury or after sphincter repair) or external sphincter altered, with an injury of a size that does not justify sphincter repair.
- Internal sphincter injuries not taken into account (by professional consensus).
Who cannot join
- Anorectal or pelvic malformations
- Local conditions incompatible with the proposed sizes of the MAS (extreme obesity, thickness of the tissue in the anorectal area)
- Sequelae of rectal resections - presence of cancer of the rectum or anus
- Rectal prolapse and/or major pelvic floor disorders
- Major chronic disorder of the intestinal motility, irritable bowel syndrome, repeated faecalomas, megarectum
- Extensive sphincter degeneration
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- Consequences of radiation-induced rectitis and chronic inflammatory diseases of the bowel (Crohn's disease)
- Neurological disorders or systemic diseases (multiple sclerosis, scleroderma, paraplegia)
- Festering sores of the perineal and/or anorectal regions
- Known or suspected risks of allergy to titanium
- Active pelvic infection
- Contraindications to SNS:
- Cardiac stimulator or defibrillator implant
- Malformation of the sacrum
- Patient exposed to Magnetic Resonance Imaging
- Skin diseases exposing the patient to the risk of infection (at the investigator's discretion)
- Patient scheduled for diathermy or ablation by radiofrequency
- Pregnant women
- Adults under guardianship
- Patients involved in a mobility project in the year following the operation
- Patient already subjected to one or other of the therapeutic approaches (MAS or SNS) Please note: coagulation problems (including anti-aggregant or anti-coagulant treatments) are not a contraindication if these problems can be corrected during the perioperative period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence
Read the detailed description
Severe anal incontinence, defined as the uncontrolled passing of stool at least once a week, is a problem that has a serious impact on the quality of life. In the event of failure of conservative treatments, surgery can help improve continence problems in a significant number of cases.
Sacral nerve stimulation is currently the standard surgical treatment for severe anal incontinence when sphincter repair (sphincteroplasty) is not recommended.
A new method of treatment based on sphincter reinforcement through the implanting of a band of magnetic beads*, has proved to be reliable and efficient on a small series of cases, particularly after the failure of sacral nerve stimulation.
The aim of our trial, which compares the "magnetic anal sphincter* and sacral nerve stimulation" in a homogeneous population of patients affected by severe anal incontinence is to define the position of this new approach in the treatment algorithm of this functional disorder, determining its clinical and medical/economic advantages compared to those of the current standard treatment.
- FenixTM (Torax Medical)
- Conditions
- Fecal Incontinence, Anal Incontinence
- Being tested
- magnetic anal sphincter, sacral nerve stimulation
- Keywords
- Fecal Incontinence., Anal Incontinence., Functional Bowel Disorders., SNS., Artificial Sphincters., Magnetic Anal Sphincter.
- 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.
magnetic anal sphincterDevice
Also called Fenix
sacral nerve stimulationDevice
Also called Interstim
| Study group | Role | What they receive |
|---|---|---|
| NMS | Active comparator | Implantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy) Receives: Device: sacral nerve stimulation |
| SAM | Experimental | Implantation under general anesthesia of magnetic anal sphincter (Fenix) Receives: Device: magnetic anal sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of fecal incontinence episodes
Average number of fecal incontinence episodes per week over a period of 3 weeks, 6 months after the implantation of a magnetic anal sphincter (FenixTM magnetic anal sphincter group) or of the Spinelli electrode during the PNE test (sacral nerve stimulation group), on the basis of a standardised stool diary
Measured: 6 months
Secondary outcomes (5)
Overall cost for the health care system
Overall cost for the health care system including implantation and follow-up - Duration and cost of hospital admissions,- Cost of covering any complications arising
Measured: 12 months
Respective complications of the two therapeutic approaches
Number and nature of the complications over 12 months, according to the Clavien-Dindo classification
Measured: 12 months
Functional results at 6 and 12 months, compared with baseline
Stool record chart, faecal incontinence score (Wexner), recourse to antidiarrhoeal treatment, the taking of analgesics, constipation score (ODS), recourse to a treatment for constipation
Measured: Baseline, 6 & 12 months
Quality of life and overall satisfaction
Quality of life and overall satisfaction of the patient at 6 and 12 months, compared with baseline:Quality of life score specific to faecal incontinence (FIQL), General quality of life scores (SF 36 and EQ-5D)
Measured: Baselnie, 6 & 12 months
Anorectal manometry data
Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume.
Measured: Baseline & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionAug 2017 (estimated)
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920607
- Sponsor's protocol ID
- RC13_0209
- Acronym
- MOS STIC
- Status last verified
- Jun 2017
- First submitted
- 8 Aug 2013
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012 Jun;14(6):e323-9. doi: 10.1111/j.1463-1318.2012.02995.x.
PubMed 22339789
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence
- ClinicalTrials.gov ID
- NCT01920607
- Acronym / sponsor ID
- MOS STIC / RC13_0209
- Conditions
- Fecal Incontinence, Anal Incontinence
- Keywords
- Fecal Incontinence., Anal Incontinence., Functional Bowel Disorders., SNS., Artificial Sphincters., Magnetic Anal Sphincter.
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: recruitment difficulties
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 Aug 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.
The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence
Detailed description
Severe anal incontinence, defined as the uncontrolled passing of stool at least once a week, is a problem that has a serious impact on the quality of life. In the event of failure of conservative treatments, surgery can help improve continence problems in a significant number of cases.
Sacral nerve stimulation is currently the standard surgical treatment for severe anal incontinence when sphincter repair (sphincteroplasty) is not recommended.
A new method of treatment based on sphincter reinforcement through the implanting of a band of magnetic beads*, has proved to be reliable and efficient on a small series of cases, particularly after the failure of sacral nerve stimulation.
The aim of our trial, which compares the "magnetic anal sphincter* and sacral nerve stimulation" in a homogeneous population of patients affected by severe anal incontinence is to define the position of this new approach in the treatment algorithm of this functional disorder, determining its clinical and medical/economic advantages compared to those of the current standard treatment.
- FenixTM (Torax Medical)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMS | Active comparator | Device: sacral nerve stimulationImplantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy) |
| SAM | Experimental | Device: magnetic anal sphincterImplantation under general anesthesia of magnetic anal sphincter (Fenix) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient (male or female) of 18 to 75 years of age
- Affected by severe anal incontinence (SAI)*.
- Documented failure of conservative treatment (reeducation and medical treatment)
- With functional anal sphincter**
- Agrees to take part in the study and has signed the informed consent form
Key exclusion criteria (21 listed)
- Anorectal or pelvic malformations
- Local conditions incompatible with the proposed sizes of the MAS (extreme obesity, thickness of the tissue in the anorectal area)
- Sequelae of rectal resections - presence of cancer of the rectum or anus
- Rectal prolapse and/or major pelvic floor disorders
- Major chronic disorder of the intestinal motility, irritable bowel syndrome, repeated faecalomas, megarectum
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 |
|---|---|---|
| magnetic anal sphincterAlso: Fenix | Device | SAM |
| sacral nerve stimulationAlso: Interstim | Device | NMS |
Primary outcome
Average number of fecal incontinence episodes
Time frame: 6 months
Average number of fecal incontinence episodes per week over a period of 3 weeks, 6 months after the implantation of a magnetic anal sphincter (FenixTM magnetic anal sphincter group) or of the Spinelli electrode during the PNE test (sacral nerve stimulation group), on the basis of a standardised stool diary
5 secondary outcomes
Overall cost for the health care system
Time frame: 12 months
Respective complications of the two therapeutic approaches
Time frame: 12 months
Functional results at 6 and 12 months, compared with baseline
Time frame: Baseline, 6 & 12 months
Quality of life and overall satisfaction
Time frame: Baselnie, 6 & 12 months
Anorectal manometry data
Time frame: Baseline & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Background: PubMed 22339789Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012 Jun;14(6):e323-9. doi: 10.1111/j.1463-1318.2012.02995.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic anal sphincter and sacral nerve stimulation in people with Fecal Incontinence and Anal Incontinence, run by Nantes University Hospital at 1 site in France.
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 9 inclusion and 21 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: paused, as of the sponsor's last update on 26 Jun 2017. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of fecal incontinence episodes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920607, which also lists 1 linked publication.
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 26 Jun 2017.