Fecal IncontinencePhase 2TENSIANCT00977652
Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
A Phase 2 study testing active stimulation in people with Fecal Incontinence, run by University Hospital, Rouen at 1 site in France.
Trial summary
Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- active stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jun 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fecal incontinence, refractory to medical treatment,for more than 3 months,with at least one episode of anal incontinence and/or urgency per month
- patient with no knowledge of cutaneous stimulation
- patients with NHS
Who cannot join
- older than 18 years old
- pregnancy
- implanted stimulator
- cutaneous lesion
- cutaneous anesthesia
- patients without oral contraception
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- Guardianship and curatorship
- fecal incontinence secondary to anorectal malformation, surgical sequelae, significative sphincteric lesion leading to repair at a first time, rectal prolapse, active neurological disease
- patient already treated by sacral nerve stimulation or stimulated graciloplasty, artificial bowel sphincter, radiofrequency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence:Randomized Controlled Study
Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant sphincteric lesions or rectal prolapse. However, the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the patients can develop a resistance to the SNS only a few months following the definite implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a new perspective. It consists in stimulating the same metameric area as the sacral nerves. It is regularly used for the treatment of urinary incontinence caused by overactive bladder. It is a non-invasive technique, causing but a few side effects. A preliminary study showed that 7 in 10 incontinent patients saw an improvement when treated with PTNS.
Purpose:
Read more
The aim of this study is to analyse and evaluate the PTNS technique in the short term as a treatment of anal incontinence. It is done through the means of a multi-centric prospective randomized study.
Patients:
Will be included: all patients followed for anal incontinence (either with liquid or solid stools) having at least one accident a month for 3months, and who are not diagnosed with colorectal lesions and who are without anal or rectal significant anatomic anomalies, without rectal prolapse, and who have failed to respond to medical treatment (such as medicine or perineal reeducation). The main criterium to analyze the efficiency will be the number of fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144 patients, that is 72 in each group. 12 centers will take part in this study, that will last 2 years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and Toulouse.
Method:
The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The electrodes are connected to an external stimulator. After having drawn lots, patients will be treated for 3months either with effective stimulation (frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by the end of the treatment.
Expected Results:
The investigators hope to prove the short term efficacy of the PTNS on anal incontinence patients.
- Conditions
- Fecal Incontinence
- Being tested
- active stimulation, sham stimulation
- Keywords
- fecal incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active stimulationProcedure or surgery
percutaneous posterior tibial nerve stimulation with following parameters: frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold during 3 months
sham stimulationProcedure or surgery
Same location with the same device than active stimulation but amplitude of stimulation = 0
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Percutaneous posterior tibial nerve stimulation Receives: Procedure: active stimulation |
| sham stimulation | Sham comparator | Inefficient percutaneous posterior tibial nerve stimulation Receives: Procedure: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal incontinence episode per week
Measured: three months
Secondary outcomes (1)
cleveland clinic score FIQL score analogic visual scale urinary score and anorectal manometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
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.
- More trials run by University Hospital, RouenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Principal investigator, Anne Marie LEROI, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977652
- Sponsor's protocol ID
- 2008/070/HP
- Other IDs
- CPP-2008/032, RCB-2008-A01227-48
- Acronym
- TENSIA
- Status last verified
- Aug 2011
- First submitted
- 15 Sep 2009
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence:Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00977652
- Acronym / sponsor ID
- TENSIA / 2008/070/HP
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Sep 2009 (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.
Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant sphincteric lesions or rectal prolapse. However, the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the patients can develop a resistance to the SNS only a few months following the definite implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a new perspective. It consists in stimulating the same metameric area as the sacral nerves. It is regularly used for the treatment of urinary incontinence caused by overactive bladder. It is a non-invasive technique, causing but a few side effects. A preliminary study showed that 7 in 10 incontinent patients saw an improvement when treated with PTNS.
Purpose:
The aim of this study is to analyse and evaluate the PTNS technique in the short term as a treatment of anal incontinence. It is done through the means of a multi-centric prospective randomized study.
Patients:
Will be included: all patients followed for anal incontinence (either with liquid or solid stools) having at least one accident a month for 3months, and who are not diagnosed with colorectal lesions and who are without anal or rectal significant anatomic anomalies, without rectal prolapse, and who have failed to respond to medical treatment (such as medicine or perineal reeducation). The main criterium to analyze the efficiency will be the number of fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144 patients, that is 72 in each group. 12 centers will take part in this study, that will last 2 years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and Toulouse.
Method:
The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The electrodes are connected to an external stimulator. After having drawn lots, patients will be treated for 3months either with effective stimulation (frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by the end of the treatment.
Expected Results:
The investigators hope to prove the short term efficacy of the PTNS on anal incontinence patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Procedure: active stimulationPercutaneous posterior tibial nerve stimulation |
| sham stimulation | Sham comparator | Procedure: sham stimulationInefficient percutaneous posterior tibial nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fecal incontinence, refractory to medical treatment,for more than 3 months,with at least one episode of anal incontinence and/or urgency per month
- patient with no knowledge of cutaneous stimulation
- patients with NHS
Key exclusion criteria (9 listed)
- older than 18 years old
- pregnancy
- implanted stimulator
- cutaneous lesion
- cutaneous anesthesia
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 |
|---|---|---|
| active stimulationpercutaneous posterior tibial nerve stimulation with following parameters: frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold during 3 months | Procedure or surgery | Active stimulation |
| sham stimulationSame location with the same device than active stimulation but amplitude of stimulation = 0 | Procedure or surgery | sham stimulation |
Primary outcome
fecal incontinence episode per week
Time frame: three months
1 secondary outcome
cleveland clinic score FIQL score analogic visual scale urinary score and anorectal manometry
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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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 Phase 2 study testing active stimulation in people with Fecal Incontinence, run by University Hospital, Rouen 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Aug 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fecal incontinence episode per week (time frame: three 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 23 Aug 2011.