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

This study has been completed.
Sponsor:
Collaborator:
North West London Hospitals NHS Trust - St. Marks Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01254695
First received: December 3, 2010
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Fecal Incontinence
 Device: Medtronic InterStim / InterStim II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Quality of life changes [ Time Frame: Will be assessed every four weeks during a twenty-week period ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of incontinence episodes [ Time Frame: Will be assessed every four weeks durring a twenty-week period ] [ Designated as safety issue: No ]
    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.

  • Days with faecal soiling [ Time Frame: Will be assessed every four weeks during a twenty-week period ] [ Designated as safety issue: No ]
    By means of a four week bowel habit diary

  • Days with faecal urgency. [ Time Frame: Will be assessed every four weeks during a twelve-week period ] [ Designated as safety issue: No ]
    By means of a four week bowel habit diary

  • Wexner incontinence score [ Time Frame: Will be assessed every four weeks during a twenty-week period ] [ Designated as safety issue: No ]
  • St. Marks Incontinence score [ Time Frame: Will be assessed every four weeks during a twenty-week period ] [ Designated as safety issue: No ]
  • Assess changes in anorectal volume and pressure with different pacemaker settings [ Time Frame: Will be assessed every four weeks during a twenty-week period ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254695

Locations
Denmark
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8200
United Kingdom
St. Marks Hospital
London, Harrow - Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
University of Aarhus
North West London Hospitals NHS Trust - St. Marks Hospital
Investigators
Principal Investigator: Jakob k Jakobsen, MD. Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01254695     History of Changes
Other Study ID Numbers: 004
Study First Received: December 3, 2010
Last Updated: November 9, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
United Kingdom: Research Ethics Committee

Keywords provided by University of Aarhus:
Idiopathic Fecal Incontinence
Fecal Incontinence
Sacral Nerve Stimulation
Sacral Nerve Neuromodulation

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 13, 2013