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| Name | Class |
|---|---|
| London North West Healthcare NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard settings | Active Comparator | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec |
|
| Experimental Setting 1 | Experimental | Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec |
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| Experimental setting 2 | Experimental | Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec |
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| Experimental setting 3 | Experimental | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec |
|
| Experimental setting 4 | Experimental | Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic InterStim / InterStim II | Device | Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jakob k Jakobsen, MD. | Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital | Aarhus | Aarhus C | 8200 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22961528 | Derived | 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. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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 |
| St. Marks Hospital |
| London |
| Harrow - Middlesex |
| HA1 3UJ |
| United Kingdom |