NCT01948973

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

4.5 years

First QC Date

September 11, 2013

Last Update Submit

May 16, 2018

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeSacral Nerve StimulationSymptomsQuality of LifeBowel habits

Outcome Measures

Primary Outcomes (1)

  • 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

    Every week during the 6 weeks test period

Secondary Outcomes (1)

  • Irritable Bowel Syndrome - Impact Scale questionnaire

    Every week during the 6 weeks test period

Other Outcomes (1)

  • Bowel habit diary

    Every day during the 6 weeks test period

Study Arms (2)

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.

Device: SubsensoryDevice: OFFDrug: 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.

Device: SubsensoryDevice: OFFDrug: Suprasensory

Interventions

SubsensoryDEVICE

The stimulation is here set to 90% of the sensory threshold

Also known as: Device: External pacemaker, model 3625, Medtronic Inc.
OFF, subsensory, suprasensorySubsensory, OFF, suprasensory
OFFDEVICE

The stimulation is here turned OFF

Also known as: Device: External pacemaker, model 3625, Medtronic Inc.
OFF, subsensory, suprasensorySubsensory, OFF, suprasensory
SuprasensoryDRUG

The stimulation is here set suprasensory

Also known as: Device: External pacemaker, model 3625, Medtronic Inc.
OFF, subsensory, suprasensorySubsensory, OFF, suprasensory

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 39754648DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Janne Fassov, PhD

    Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 24, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

DK(1)