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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Aarhus

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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
  • 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
  • Wexner incontinence score [ Time Frame: 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 ]
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: December 3, 2010
Date Started: July 2010
Date Completion:
Last Updated: November 9, 2011
Last Verified: November 2011