Fecal IncontinenceSNSNCT00913601
Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?
A study testing Medtronic INTERSIM II - 3058 in people with Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial summary
Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. 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?
- Medtronic INTERSIM II - 3058
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
- Age> 40 years normal sigmoid/colonoscopic prior to operation
Who cannot join
- Pregnant or breastfeeding
- Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
- Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliaki, neurological disorders.
- Irritable Bowel Syndrome
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Official title: Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.
Read the detailed description
Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve stimulation was used for three patients with faecal incontinence, two were afterwards fully continent. The method has over the last decade been used increasingly in Europe. The method is now used routinely in the treatment of faecal incontinence in Europe.
Recent studies have shown that the effect of sacral nerve stimulation is due to a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to anal sphincter and the pelvic floor has less significance.
The sacral nerve stimulation is performed in two steps, first a test stimulation, if positive the patients proceed to permanent implant.
Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode and neurostimulator are implanted. The test period has a success rate of approximately 75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery. These 75-80% will normal be candidates to unilateral implantation of permanent electrode and neurostimulator.
All permanently implanted has less incontinence symptoms after the treatment. Satisfactory continence results after permanent implantation are seen in 70% of the patients, the remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could have a more optimal function if they were stimulate on more than one sacral nerve simultaneously.
Hypothesis: Is it possible to improve the functional result in faecal incontinent patients treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves bilaterally.
- Conditions
- Fecal Incontinence
- Being tested
- Medtronic INTERSIM II - 3058
- Keywords
- Idiopathic Fecal Incontinence, Fecal Incontinence, Sacral Nerve Stimulation, Sacral Nerve Neuromodulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic INTERSIM II - 3058Device
Also called Impuls Generator
Medtronic INTERSIM II - 3058 Impuls Generator
| Study group | Role | What they receive |
|---|---|---|
| Dextra | Experimental | Unilateral sacral nerve stimulation dextra for 4 weeks Receives: Device: Medtronic INTERSIM II - 3058 |
| Sinistra | Experimental | Unilateral sacral nerve stimulation sinistra 4 weeks Receives: Device: Medtronic INTERSIM II - 3058 |
| Bilateral | Experimental | Bilateral sacral nerve stimulation 4 weeks Receives: Device: Medtronic INTERSIM II - 3058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of faecal incontinence episodes per week.
Measured: 1, 2, and 3 months after enrolment to the project
Secondary outcomes (5)
Days with faecal soiling.
Measured: 1, 2, and 3 months after enrolment to the project
Days with faecal urgency.
Measured: 1, 2, and 3 months after enrolment to the project
Wexner incontinence score.
Measured: 1, 2, and 3 months after enrolment to the project
Anal physiological changes during SNS bilateral versus unilateral.
Measured: 1, 2, and 3 months after enrolment to the project
Quality of life assessment (Rockwood - Fecal incontinence quality of life)
Measured: 1, 2, and 3 months after enrolment to the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2013
- Study completionJul 2013
Why it stopped: Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
- Responsible party
- Principal investigator, Jakob Jakobsen, University of Aarhus
- Investigators
- Jakob K Jakobsen, MD, Principal investigator, Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913601
- Sponsor's protocol ID
- 001
- Acronym
- SNS
- Status last verified
- Jul 2014
- First submitted
- 2 Jun 2009
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.
PubMed 7475602Vaizey CJ, Kamm MA, Turner IC, Nicholls RJ, Woloszko J. Effects of short term sacral nerve stimulation on anal and rectal function in patients with anal incontinence. Gut. 1999 Mar;44(3):407-12. doi: 10.1136/gut.44.3.407.
PubMed 10026329Rasmussen OO, Christiansen J. [Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish.
PubMed 12216156Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA. Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. doi: 10.1002/bjs.4796.
PubMed 15455360Michelsen HB, Buntzen S, Krogh K, Laurberg S. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum. 2006 Jul;49(7):1039-44. doi: 10.1007/s10350-006-0548-8.
PubMed 16721520
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT00913601
- Acronym / sponsor ID
- SNS / 001
- Conditions
- Fecal Incontinence
- Keywords
- Idiopathic Fecal Incontinence, Fecal Incontinence, Sacral Nerve Stimulation, Sacral Nerve Neuromodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
- Study start
- May 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Jun 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.
Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.
Detailed description
Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve stimulation was used for three patients with faecal incontinence, two were afterwards fully continent. The method has over the last decade been used increasingly in Europe. The method is now used routinely in the treatment of faecal incontinence in Europe.
Recent studies have shown that the effect of sacral nerve stimulation is due to a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to anal sphincter and the pelvic floor has less significance.
The sacral nerve stimulation is performed in two steps, first a test stimulation, if positive the patients proceed to permanent implant.
Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode and neurostimulator are implanted. The test period has a success rate of approximately 75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery. These 75-80% will normal be candidates to unilateral implantation of permanent electrode and neurostimulator.
All permanently implanted has less incontinence symptoms after the treatment. Satisfactory continence results after permanent implantation are seen in 70% of the patients, the remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could have a more optimal function if they were stimulate on more than one sacral nerve simultaneously.
Hypothesis: Is it possible to improve the functional result in faecal incontinent patients treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves bilaterally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextra | Experimental | Device: Medtronic INTERSIM II - 3058Unilateral sacral nerve stimulation dextra for 4 weeks |
| Sinistra | Experimental | Device: Medtronic INTERSIM II - 3058Unilateral sacral nerve stimulation sinistra 4 weeks |
| Bilateral | Experimental | Device: Medtronic INTERSIM II - 3058Bilateral sacral nerve stimulation 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent
- Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
- Age> 40 years normal sigmoid/colonoscopic prior to operation
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
- Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliaki, neurological disorders.
- Irritable Bowel Syndrome
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 |
|---|---|---|
| Medtronic INTERSIM II - 3058Also: Impuls GeneratorMedtronic INTERSIM II - 3058 Impuls Generator | Device | Bilateral, Dextra, Sinistra |
Primary outcome
Number of faecal incontinence episodes per week.
Time frame: 1, 2, and 3 months after enrolment to the project
5 secondary outcomes
Days with faecal soiling.
Time frame: 1, 2, and 3 months after enrolment to the project
Days with faecal urgency.
Time frame: 1, 2, and 3 months after enrolment to the project
Wexner incontinence score.
Time frame: 1, 2, and 3 months after enrolment to the project
Anal physiological changes during SNS bilateral versus unilateral.
Time frame: 1, 2, and 3 months after enrolment to the project
Quality of life assessment (Rockwood - Fecal incontinence quality of life)
Time frame: 1, 2, and 3 months after enrolment to the project
Results and safety
The study was stopped early (reason given: Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Background: PubMed 7475602Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.
- Background: PubMed 10026329Vaizey CJ, Kamm MA, Turner IC, Nicholls RJ, Woloszko J. Effects of short term sacral nerve stimulation on anal and rectal function in patients with anal incontinence. Gut. 1999 Mar;44(3):407-12. doi: 10.1136/gut.44.3.407.
- Background: PubMed 12216156Rasmussen OO, Christiansen J. [Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish.
- Background: PubMed 15455360Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA. Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. doi: 10.1002/bjs.4796.
- Background: PubMed 16721520Michelsen HB, Buntzen S, Krogh K, Laurberg S. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum. 2006 Jul;49(7):1039-44. doi: 10.1007/s10350-006-0548-8.
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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.
Jakob K Jakobsen, MD principal investigator
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic INTERSIM II - 3058 in people with Fecal Incontinence, run by University of Aarhus 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Jul 2014. 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?
The study was stopped early (reason given: Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.). 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?
Number of faecal incontinence episodes per week. (time frame: 1, 2, and 3 months after enrolment to the project). 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 NCT00913601, which also lists 5 linked publications.
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 3 Jul 2014.