Irritable Bowel SyndromeNCT01948973
Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
A study testing Subsensory, OFF and Suprasensory 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 changes in both colonic motility and rectal sensibility. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Subsensory, OFF and Suprasensory
- 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
- Sep 2013to Mar 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- 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-D or IBS-M according to the Rome III criteria
- Minimum average of 40 points in the symptom quistionnaire evaluated at baseline
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
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
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 changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.
Read the detailed description
Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.
Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks.
During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Subsensory, OFF, Suprasensory
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life, Bowel habits
- 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.
SubsensoryDevice
Also called Device: External pacemaker, model 3625, Medtronic Inc.
The stimulation is here set to 90% of the sensory threshold
OFFDevice
Also called Device: External pacemaker, model 3625, Medtronic Inc.
The stimulation is here turned OFF
SuprasensoryDrug
Also called Device: External pacemaker, model 3625, Medtronic Inc.
The stimulation is here set suprasensory
| Study group | Role | What they receive |
|---|---|---|
| OFF, subsensory, suprasensory | Active comparator | Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks. Receives: Device: Subsensory; Device: OFF; Drug: Suprasensory |
| Subsensory, OFF, suprasensory | Active comparator | Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks. Receives: Device: Subsensory; Device: OFF; Drug: Suprasensory |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation
Measured: Every week during the 6 weeks test period
Secondary outcomes (1)
Irritable Bowel Syndrome - Impact Scale questionnaire
The IBS-IS questionnaire is filled in every week during the test period allowing comparison of quality of life between OFF, subsensory and suprasensory stimulation
Measured: Every week during the 6 weeks test period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2018
- Study completionMar 2018
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.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Janne Fassov, PhD, Principal investigator, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948973
- Sponsor's protocol ID
- 1-10-72-170-13, JLF
- Other IDs
- 1-10-72-170-13
- Status last verified
- May 2018
- First submitted
- 11 Sep 2013
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fassov J, Hoyer KL, Lundby L, Laurberg S, Scott SM, Krogh K. Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome. Tech Coloproctol. 2025 Jan 4;29(1):41. doi: 10.1007/s10151-024-03066-3.
PubMed 39754648
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
- A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01948973
- Acronym / sponsor ID
- 1-10-72-170-13, JLF
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life, Bowel habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 24 Sep 2013 (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 changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.
Detailed description
Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.
Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks.
During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFF, subsensory, suprasensory | Active comparator | Device: Subsensory, Device: OFF, Drug: SuprasensoryHere the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks. |
| Subsensory, OFF, suprasensory | Active comparator | Device: Subsensory, Device: OFF, Drug: SuprasensoryHere the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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-D or IBS-M according to the Rome III criteria
- Minimum average of 40 points in the symptom quistionnaire evaluated at baseline
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 |
|---|---|---|
| SubsensoryAlso: Device: External pacemaker, model 3625, Medtronic Inc.The stimulation is here set to 90% of the sensory threshold | Device | OFF, subsensory, suprasensory, Subsensory, OFF, suprasensory |
| OFFAlso: Device: External pacemaker, model 3625, Medtronic Inc.The stimulation is here turned OFF | Device | OFF, subsensory, suprasensory, Subsensory, OFF, suprasensory |
| SuprasensoryAlso: Device: External pacemaker, model 3625, Medtronic Inc.The stimulation is here set suprasensory | Drug | OFF, subsensory, suprasensory, Subsensory, OFF, suprasensory |
Primary outcome
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
Time frame: Every week during the 6 weeks test period
The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation
1 secondary outcome
Irritable Bowel Syndrome - Impact Scale questionnaire
Time frame: Every week during the 6 weeks test 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 17 May 2018.
- Derived from this study: PubMed 39754648Fassov J, Hoyer KL, Lundby L, Laurberg S, Scott SM, Krogh K. Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome. Tech Coloproctol. 2025 Jan 4;29(1):41. doi: 10.1007/s10151-024-03066-3.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
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.
Janne Fassov, PhD principal investigator
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subsensory, OFF and Suprasensory 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?
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire (time frame: Every week during the 6 weeks test 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 NCT01948973, 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.