Fecal IncontinenceSNStestNCT00522691
Efficacy of Sacral Nerve Stimulation Before Definitive Implantation
A study testing sacral nerve stimulation in people with Fecal Incontinence, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- sacral nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Dec 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to SNS test for treatment of faecal incontinence after unsuccessful conservative (or surgical) treatment.
Who cannot join
- Absence of informed consent.
- Patients not speaking french or german.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Visceral surgery, university hospital
Lausanne, Canton of Vaud, 1005
About this study
Official title: Efficacy of Sacral Nerve Stimulation Before Definitive Implantation: a Multicenter Randomized, Double Blind, Crossover Trial
Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. A careful patent selection for definite implantation is therefore crucial. However, indication for implantation is actually based only on the subjective criteria reported in the patients´ diary only. Patients and care providers are likely to overestimate the real effect of SNS leading to an unjustified overuse of this expensive device. It is therefore necessary to evaluate real efficacy of SNS during the testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.
Read the detailed description
Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe faecal incontinence when conservative measures fail and surgical repair is not indicated. In a minimally-invasive approach and under local anaesthesia, an electrode is placed around sacral nerve root S2-4 and electrical stimulation is applied to the sacral spinal nerves. Effectiveness of SNS is definitively not only explained by placebo effect but the pathophysiologic mechanisms remain unclear. Suggested pathways include modulation of afferent nerve fibres and direct stimulation of the pelvic floor and anal sphincter muscle. After placement of the electrode, the patient is stimulated by an external stimulator for 1-3 weeks. During this period, the patient documents the number of faecal incontinence episodes or urgencies in a symptom diary. By convention, indication for permanent stimulation is based on a 50% reduction in the number of episodes. After a successful testing period, the permanent stimulator is implanted, generally in the upper gluteal region.
Previous studies report success rates up to 80%. The only randomized trial with a proper sample size evaluated the efficacy of SNS after definite implantation. In this study, 63% of the patients felt improved during the placebo period and might not really benefit from the device. The real success rate of SNS is therefore likely to be considerably lower. Efficacy of SNS during the testing phase has never been assessed in a blinded randomized study.
- Conditions
- Fecal Incontinence
- Being tested
- sacral nerve stimulation
- Keywords
- Fecal incontinence, sacral nerve stimulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral nerve stimulationProcedure or surgery
sacral nerve stimulation for fecal incontinence
| Study group | Role | What they receive |
|---|---|---|
| A: sacral first | Experimental | Phase 1: sacral nerve stimulation crossover Phase 2 : sham stimulation Receives: Procedure: sacral nerve stimulation |
| B: sham first | Experimental | Phase 1: sham stimulation crossover Phase 2: sacral nerve stimulation Receives: Procedure: sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary success rate of SNS after 7 days. By convention this is assessed by >50% reduction in the number of episodes in the symptom diary.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: slow recruitment
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Martin Hubner, MD, Principal investigator, Visceral Surgery, University Lausanne, SwitzerlandJean-Claude Givel, Professor, Study director, Visceral Surgery, University Lausanne, SwitzerlandNicolas Demartines, Professor, Study chair, Visceral Surgery, University Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522691
- Sponsor's protocol ID
- CHV120/07
- Acronym
- SNStest
- Status last verified
- Jun 2015
- First submitted
- 28 Aug 2007
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sacral Nerve Stimulation Before Definitive Implantation: a Multicenter Randomized, Double Blind, Crossover Trial
- ClinicalTrials.gov ID
- NCT00522691
- Acronym / sponsor ID
- SNStest / CHV120/07
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, sacral nerve stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Aug 2007 (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.
Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. A careful patent selection for definite implantation is therefore crucial. However, indication for implantation is actually based only on the subjective criteria reported in the patients´ diary only. Patients and care providers are likely to overestimate the real effect of SNS leading to an unjustified overuse of this expensive device. It is therefore necessary to evaluate real efficacy of SNS during the testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.
Detailed description
Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe faecal incontinence when conservative measures fail and surgical repair is not indicated. In a minimally-invasive approach and under local anaesthesia, an electrode is placed around sacral nerve root S2-4 and electrical stimulation is applied to the sacral spinal nerves. Effectiveness of SNS is definitively not only explained by placebo effect but the pathophysiologic mechanisms remain unclear. Suggested pathways include modulation of afferent nerve fibres and direct stimulation of the pelvic floor and anal sphincter muscle. After placement of the electrode, the patient is stimulated by an external stimulator for 1-3 weeks. During this period, the patient documents the number of faecal incontinence episodes or urgencies in a symptom diary. By convention, indication for permanent stimulation is based on a 50% reduction in the number of episodes. After a successful testing period, the permanent stimulator is implanted, generally in the upper gluteal region.
Previous studies report success rates up to 80%. The only randomized trial with a proper sample size evaluated the efficacy of SNS after definite implantation. In this study, 63% of the patients felt improved during the placebo period and might not really benefit from the device. The real success rate of SNS is therefore likely to be considerably lower. Efficacy of SNS during the testing phase has never been assessed in a blinded randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: sacral first | Experimental | Procedure: sacral nerve stimulationPhase 1: sacral nerve stimulation crossover Phase 2 : sham stimulation |
| B: sham first | Experimental | Procedure: sacral nerve stimulationPhase 1: sham stimulation crossover Phase 2: sacral nerve stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to SNS test for treatment of faecal incontinence after unsuccessful conservative (or surgical) treatment.
Key exclusion criteria (2 listed)
- Absence of informed consent.
- Patients not speaking french or german.
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 |
|---|---|---|
| sacral nerve stimulationsacral nerve stimulation for fecal incontinence | Procedure or surgery | A: sacral first, B: sham first |
Primary outcome
Primary success rate of SNS after 7 days. By convention this is assessed by >50% reduction in the number of episodes in the symptom diary.
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
Related trials for Fecal Incontinence
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Active, not recruitingPhase 2/3
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Fecal Incontinence
Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
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.
Martin Hubner, MD principal investigator
Visceral Surgery, University Lausanne, Switzerland
Jean-Claude Givel, Professor study director
Visceral Surgery, University Lausanne, Switzerland
Nicolas Demartines, Professor study chair
Visceral Surgery, University Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacral nerve stimulation in people with Fecal Incontinence, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 24 Jun 2015. 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 Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary success rate of SNS after 7 days. By convention this is assessed by >50% reduction in the number of episodes in the symptom diary. (time frame: 24 months). 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 24 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.