Fecal IncontinenceNCT01254695
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
A study testing Medtronic InterStim / InterStim II in people with Fecal Incontinence, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. 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 InterStim / InterStim II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2010to Jun 2011
- 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,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
- Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
- minimum one incontinence episodes pr. week during ongoing SNS-therapy
Who cannot join
- Colorectal surgery after IPG-implantation
- Pregnancy or breastfeeding
- Anal/perianal pain or discomfort
- 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, coeliac, neurological disorders.
- Spinal cord injury
- Irritable Bowel Syndrome
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8200
United Kingdom1 site
St. Marks Hospital
London, Harrow - Middlesex, HA1 3UJ
About this study
Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.
Read the detailed description
Faecal incontinence is a devastating condition affecting daily living and has major influences on 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, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.
The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.
Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.
- Conditions
- Fecal Incontinence
- Being tested
- Medtronic InterStim / InterStim II
- 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 InterStim / InterStim IIDevice
Also called Medtronic InterStim, Medtronic InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
| Study group | Role | What they receive |
|---|---|---|
| Standard settings | Active comparator | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec Receives: Device: Medtronic InterStim / InterStim II |
| Experimental Setting 1 | Experimental | Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec Receives: Device: Medtronic InterStim / InterStim II |
| Experimental setting 2 | Experimental | Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec Receives: Device: Medtronic InterStim / InterStim II |
| Experimental setting 3 | Experimental | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec Receives: Device: Medtronic InterStim / InterStim II |
| Experimental setting 4 | Experimental | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec Receives: Device: Medtronic InterStim / InterStim II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life changes
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.
Measured: Will be assessed every four weeks during a twenty-week period
Secondary outcomes (6)
Number of incontinence episodes
Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated five times during the twenty-week protocol perioed.
Measured: Will be assessed every four weeks durring a twenty-week period
Days with faecal soiling
By means of a four week bowel habit diary
Measured: Will be assessed every four weeks during a twenty-week period
Days with faecal urgency.
By means of a four week bowel habit diary
Measured: Will be assessed every four weeks during a twelve-week period
Wexner incontinence score
Measured: Will be assessed every four weeks during a twenty-week period
St. Marks Incontinence score
Measured: Will be assessed every four weeks during a twenty-week period
Assess changes in anorectal volume and pressure with different pacemaker settings
Resting, maximal anal sphincter pressure and rectal filling(first sensation, urge to defacate and maximal tolerabel volume(Air))pressure will be measured with different pacemaker settings. In total five evaluations will be made in the twenty week protocol perioed.
Measured: Will be assessed every four weeks during a twenty-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionJun 2011
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 University of AarhusThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Responsible party
- Sponsor
- 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
- NCT01254695
- Sponsor's protocol ID
- 004
- Status last verified
- Nov 2011
- First submitted
- 3 Dec 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duelund-Jakobsen J, Dudding T, Bradshaw E, Buntzen S, Lundby L, Laurberg S, Vaizey C. Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence. Br J Surg. 2012 Oct;99(10):1445-52. doi: 10.1002/bjs.8867.
PubMed 22961528
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
- ClinicalTrials.gov ID
- NCT01254695
- Acronym / sponsor ID
- 004
- Conditions
- Fecal Incontinence
- Keywords
- Idiopathic Fecal Incontinence, Fecal Incontinence, Sacral Nerve Stimulation, Sacral Nerve Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Dec 2010 (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 affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.
Detailed description
Faecal incontinence is a devastating condition affecting daily living and has major influences on 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, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.
The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.
Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard settings | Active comparator | Device: Medtronic InterStim / InterStim IIAmplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec |
| Experimental Setting 1 | Experimental | Device: Medtronic InterStim / InterStim IIAmplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec |
| Experimental setting 2 | Experimental | Device: Medtronic InterStim / InterStim IIAmplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec |
| Experimental setting 3 | Experimental | Device: Medtronic InterStim / InterStim IIAmplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec |
| Experimental setting 4 | Experimental | Device: Medtronic InterStim / InterStim IIAmplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent
- Diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
- Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
- minimum one incontinence episodes pr. week during ongoing SNS-therapy
Key exclusion criteria (7 listed)
- Colorectal surgery after IPG-implantation
- Pregnancy or breastfeeding
- Anal/perianal pain or discomfort
- 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, coeliac, neurological disorders.
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 InterStim / InterStim IIAlso: Medtronic InterStim, Medtronic InterStim IIStandard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4 | Device | Experimental Setting 1, Experimental setting 2, Experimental setting 3, Experimental setting 4, Standard settings |
Primary outcome
Quality of life changes
Time frame: Will be assessed every four weeks during a twenty-week period
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.
6 secondary outcomes
Number of incontinence episodes
Time frame: Will be assessed every four weeks durring a twenty-week period
Days with faecal soiling
Time frame: Will be assessed every four weeks during a twenty-week period
Days with faecal urgency.
Time frame: Will be assessed every four weeks during a twelve-week period
Wexner incontinence score
Time frame: Will be assessed every four weeks during a twenty-week period
St. Marks Incontinence score
Time frame: Will be assessed every four weeks during a twenty-week period
Assess changes in anorectal volume and pressure with different pacemaker settings
Time frame: Will be assessed every four weeks during a twenty-week period
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 10 Nov 2011.
- Derived from this study: PubMed 22961528Duelund-Jakobsen J, Dudding T, Bradshaw E, Buntzen S, Lundby L, Laurberg S, Vaizey C. Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence. Br J Surg. 2012 Oct;99(10):1445-52. doi: 10.1002/bjs.8867.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic InterStim / InterStim II in people with Fecal Incontinence, run by University of Aarhus at 2 sites in 2 countries.
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 7 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, United Kingdom. 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 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?
Quality of life changes (time frame: Will be assessed every four weeks during a twenty-week period). 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 NCT01254695, 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 10 Nov 2011.