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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

December 3, 2010
November 9, 2011
July 2010
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01254695 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinence
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
  • Active Comparator: Standard settings
    Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec
    Intervention: Device: Medtronic InterStim / InterStim II
  • Experimental: Experimental Setting 1
    Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec
    Intervention: Device: Medtronic InterStim / InterStim II
  • Experimental: Experimental setting 2
    Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec
    Intervention: Device: Medtronic InterStim / InterStim II
  • Experimental: Experimental setting 3
    Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec
    Intervention: Device: Medtronic InterStim / InterStim II
  • Experimental: Experimental setting 4
    Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec
    Intervention: Device: Medtronic InterStim / InterStim II
Duelund-Jakobsen J, Dudding T, Bradshaw E, Buntzen S, Lundby L, Laurberg S, Vaizey C. Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence. Br J Surg. 2012 Oct;99(10):1445-52. doi: 10.1002/bjs.8867.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United Kingdom
 
NCT01254695
004
Yes
University of Aarhus
University of Aarhus
North West London Hospitals NHS Trust - St. Marks Hospital
Principal Investigator: Jakob k Jakobsen, MD. Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
University of Aarhus
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP