Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

November 9, 2011 updated by: University of Aarhus
Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Faecal incontinence is a devastating condition affecting daily living and has major influences on 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, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.

The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.

Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.

Study Type

Interventional

Enrollment (Actual)

15

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, 8200
        • Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
  • United Kingdom
    • Harrow - Middlesex
      • London, Harrow - Middlesex, United Kingdom, HA1 3UJ
        • St. Marks 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

18 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,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
  • Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
  • minimum one incontinence episodes pr. week during ongoing SNS-therapy

Exclusion Criteria:

  • Colorectal surgery after IPG-implantation
  • Pregnancy or breastfeeding
  • Anal/perianal pain or discomfort
  • 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, coeliac, neurological disorders.
  • Spinal cord injury
  • 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard settings
Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec
Device: Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Other Names:
  • Medtronic InterStim
  • Medtronic InterStim II
EXPERIMENTAL: Experimental Setting 1
Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec
Device: Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Other Names:
  • Medtronic InterStim
  • Medtronic InterStim II
EXPERIMENTAL: Experimental setting 2
Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec
Device: Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Other Names:
  • Medtronic InterStim
  • Medtronic InterStim II
EXPERIMENTAL: Experimental setting 3
Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec
Device: Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Other Names:
  • Medtronic InterStim
  • Medtronic InterStim II
EXPERIMENTAL: Experimental setting 4
Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec
Device: Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Other Names:
  • Medtronic InterStim
  • Medtronic InterStim II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life changes
Time Frame: Will be assessed every four weeks during a twenty-week period
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.
Will be assessed every four weeks during a twenty-week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of incontinence episodes
Time Frame: Will be assessed every four weeks durring a twenty-week period
Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated five times during the twenty-week protocol perioed.
Will be assessed every four weeks durring a twenty-week period
Days with faecal soiling
Time Frame: Will be assessed every four weeks during a twenty-week period
By means of a four week bowel habit diary
Will be assessed every four weeks during a twenty-week period
Days with faecal urgency.
Time Frame: Will be assessed every four weeks during a twelve-week period
By means of a four week bowel habit diary
Will be assessed every four weeks during a twelve-week period
Wexner incontinence score
Time Frame: Will be assessed every four weeks during a twenty-week period
Will be assessed every four weeks during a twenty-week period
St. Marks Incontinence score
Time Frame: Will be assessed every four weeks during a twenty-week period
Will be assessed every four weeks during a twenty-week period
Assess changes in anorectal volume and pressure with different pacemaker settings
Time Frame: Will be assessed every four weeks during a twenty-week period
Resting, maximal anal sphincter pressure and rectal filling(first sensation, urge to defacate and maximal tolerabel volume(Air))pressure will be measured with different pacemaker settings. In total five evaluations will be made in the twenty week protocol perioed.
Will be assessed every four weeks during a twenty-week period

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

London North West Healthcare NHS Trust

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

July 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (ESTIMATE)

December 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

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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