Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally? (SNS)

July 2, 2014 updated by: Jakob Jakobsen, University of Aarhus

Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial

Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences 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, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve stimulation was used for three patients with faecal incontinence, two were afterwards fully continent. The method has over the last decade been used increasingly in Europe. The method is now used routinely in the treatment of faecal incontinence in Europe.

Recent studies have shown that the effect of sacral nerve stimulation is due to a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to anal sphincter and the pelvic floor has less significance.

The sacral nerve stimulation is performed in two steps, first a test stimulation, if positive the patients proceed to permanent implant.

Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode and neurostimulator are implanted. The test period has a success rate of approximately 75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery. These 75-80% will normal be candidates to unilateral implantation of permanent electrode and neurostimulator.

All permanently implanted has less incontinence symptoms after the treatment. Satisfactory continence results after permanent implantation are seen in 70% of the patients, the remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could have a more optimal function if they were stimulate on more than one sacral nerve simultaneously.

Hypothesis: Is it possible to improve the functional result in faecal incontinent patients treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves bilaterally.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent
  • Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
  • Age> 40 years normal sigmoid/colonoscopic prior to operation

Exclusion Criteria:

  • Pregnant or breastfeeding
  • 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, coeliaki, neurological disorders.
  • Irritable Bowel Syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextra
Unilateral sacral nerve stimulation dextra for 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Impuls Generator
Experimental: Sinistra
Unilateral sacral nerve stimulation sinistra 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Impuls Generator
Experimental: Bilateral
Bilateral sacral nerve stimulation 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Impuls Generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of faecal incontinence episodes per week.
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project

Secondary Outcome Measures

Outcome Measure
Time Frame
Days with faecal soiling.
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project
Days with faecal urgency.
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project
Wexner incontinence score.
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project
Anal physiological changes during SNS bilateral versus unilateral.
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project
Quality of life assessment (Rockwood - Fecal incontinence quality of life)
Time Frame: 1, 2, and 3 months after enrolment to the project
1, 2, and 3 months after enrolment to the project

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark

Investigators

  • Principal Investigator: Jakob K Jakobsen, MD, Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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