Irritable Bowel SyndromeNCT00919672
Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation
A study testing Sacral nerve stimulation in people with Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Sacral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Nov 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
- Patients aged over 18
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- Patients who are diagnosed with IBS according to the Rome III criteria
- Minimum 30% reduction of the IBS symptoms during the PNE-test (a criteria for implantation of the neurostimulator)
Who cannot join
- Overt bowel diseases including inflammatory bowel disease
- Pregnant or breast feeding
- Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
- Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Analfysiologisk Klinik, University Hospital of Aarhus
Aarhus, 8000
About this study
Official title: Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation. A Blinded, Randomized Crossover Study
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. This modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with IBS.
Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III criteria, and also satisfy the criteria for implantation of a neurostimulator.
Read more
After a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON stimulation in a 2-month period.
At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System (MTS) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum.
This is based on the study hypothesis that the motility of the small intestine and the colon is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the motility of the small intestine and the colon in IBS patients as well as SNS will affect the perception of pain/discomfort in the rectum in IBS patients.
The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of patients with IBS with SNS will be evaluated.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Sacral nerve stimulation
- Keywords
- Irritable bowel syndrome, Sacral nerve stimulation, Motility, Pain perception, GSRS-IBS, IBS-IS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral nerve stimulationDevice
Also called Irritable Bowel Syndrome
The stimulation is set individually to provide the best possible stimulation for each individual person. This setting is found before the study starts and will not be altered during the study.
| Study group | Role | What they receive |
|---|---|---|
| Sacral nerve stimulation ON-OFF | Active comparator | As previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period. Receives: Device: Sacral nerve stimulation |
| Sacral nerve stimulation OFF-ON | Active comparator | As previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period. Receives: Device: Sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the investigations with MTS and impedance planimetry as well as the GSRS-IBS and IBS-IS scores in the the two periods (ON/OFF periods) in the single IBS patient. Nonparametrics tests.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionNov 2013
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 Irritable Bowel SyndromeStudies 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Lilli Lundbye, PhD, Study director, Analfysiologisk Klinik, University Hospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919672
- Sponsor's protocol ID
- 20070218,JLF
- Status last verified
- May 2018
- First submitted
- 25 May 2009
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fassov J, Lundby L, Worsoe J, Buntzen S, Laurberg S, Krogh K. A randomised, controlled study of small intestinal motility in patients treated with sacral nerve stimulation for irritable bowel syndrome. BMC Gastroenterol. 2014 Jun 25;14:111. doi: 10.1186/1471-230X-14-111.
PubMed 24965754
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation. A Blinded, Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT00919672
- Acronym / sponsor ID
- 20070218,JLF
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Sacral nerve stimulation, Motility, Pain perception, GSRS-IBS, IBS-IS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 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.
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. This modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with IBS.
Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III criteria, and also satisfy the criteria for implantation of a neurostimulator.
After a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON stimulation in a 2-month period.
At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System (MTS) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum.
This is based on the study hypothesis that the motility of the small intestine and the colon is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the motility of the small intestine and the colon in IBS patients as well as SNS will affect the perception of pain/discomfort in the rectum in IBS patients.
The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of patients with IBS with SNS will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral nerve stimulation ON-OFF | Active comparator | Device: Sacral nerve stimulationAs previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period. |
| Sacral nerve stimulation OFF-ON | Active comparator | Device: Sacral nerve stimulationAs previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- Patients who are diagnosed with IBS according to the Rome III criteria
- Minimum 30% reduction of the IBS symptoms during the PNE-test (a criteria for implantation of the neurostimulator)
Key exclusion criteria (4 listed)
- Overt bowel diseases including inflammatory bowel disease
- Pregnant or breast feeding
- Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
- Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease
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 stimulationAlso: Irritable Bowel SyndromeThe stimulation is set individually to provide the best possible stimulation for each individual person. This setting is found before the study starts and will not be altered during the study. | Device | Sacral nerve stimulation OFF-ON, Sacral nerve stimulation ON-OFF |
Primary outcome
Comparing the investigations with MTS and impedance planimetry as well as the GSRS-IBS and IBS-IS scores in the the two periods (ON/OFF periods) in the single IBS patient. Nonparametrics tests.
Time frame: 2 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 17 May 2018.
- Derived from this study: PubMed 24965754Fassov J, Lundby L, Worsoe J, Buntzen S, Laurberg S, Krogh K. A randomised, controlled study of small intestinal motility in patients treated with sacral nerve stimulation for irritable bowel syndrome. BMC Gastroenterol. 2014 Jun 25;14:111. doi: 10.1186/1471-230X-14-111.
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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.
Lilli Lundbye, PhD study director
Analfysiologisk Klinik, University Hospital of Aarhus
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 Irritable Bowel Syndrome, 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 4 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: finished, as of the sponsor's last update on 17 May 2018. 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 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?
Comparing the investigations with MTS and impedance planimetry as well as the GSRS-IBS and IBS-IS scores in the the two periods (ON/OFF periods) in the single IBS patient. Nonparametrics tests. (time frame: 2 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 NCT00919672, 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 17 May 2018.