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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Medtronic InterStim / InterStim II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard settings<br>Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec | Device: Medtronic InterStim / InterStim II<br>* Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4<br>* Other names: Medtronic InterStim II;|
| Experimental: Experimental Setting 1<br>Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec | Device: Medtronic InterStim / InterStim II<br>* Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4<br>* Other names: Medtronic InterStim II;|
| Experimental: Experimental setting 2<br>Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec | Device: Medtronic InterStim / InterStim II<br>* Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4<br>* Other names: Medtronic InterStim II;|
| Experimental: Experimental setting 3<br>Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec | Device: Medtronic InterStim / InterStim II<br>* Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4<br>* Other names: Medtronic InterStim II;|
| Experimental: Experimental setting 4<br>Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec | Device: Medtronic InterStim / InterStim II<br>* Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4<br>* Other names: Medtronic InterStim II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life changes | 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 | 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 | By means of a four week bowel habit diary | Will be assessed every four weeks during a twenty-week period | 
| Days with faecal urgency. | By means of a four week bowel habit diary | Will be assessed every four weeks during a twelve-week period | 
| Wexner incontinence score |  | Will be assessed every four weeks during a twenty-week period | 
| St. Marks Incontinence score |  | Will be assessed every four weeks during a twenty-week period | 
| Assess changes in anorectal volume and pressure with different pacemaker settings | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Fecal Incontinence, Fecal Incontinence, Sacral Nerve Stimulation, Sacral Nerve Neuromodulation