NCT01950715

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. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 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 21, 2018

Status Verified

May 1, 2018

Enrollment Period

4.5 years

First QC Date

September 12, 2013

Last Update Submit

May 16, 2018

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeSacral Nerve StimulationGastro-colic responseMultimodal Stimulation

Outcome Measures

Primary Outcomes (1)

  • Cross sectional area

    Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation

    Change from baseline in cross sectional area at 6 weeks of stimulation

Secondary Outcomes (4)

  • Wall stiffness

    Change from baseline in wall stiffness at 6 weeks of stimulation

  • Compliance

    Change from baseline in compliance at 6 weeks of stimulation

  • Cold

    Change from baseline in cold tolerance at 6 weeks of stimulation

  • Heat

    Change from baseline in heat tolerance at 6 weeks of stimulation

Study Arms (1)

sacral nerve stimulation

OTHER

A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation

Device: sacral nerve stimulation

Interventions

sacral nerve stimulationDEVICE

Sacral nerve stimulation

Also known as: External pacemaker, model 3625, Medtronic Inc.
sacral nerve stimulation

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 questionnaire 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

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

DK(1)