Fecal Incontinence
Conditions
Keywords
Idiopathic Fecal Incontinence, Fecal Incontinence, Sacral Nerve Stimulation, Sacral Nerve Neuromodulation
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 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.
Interventions
DEVICEMedtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Sponsors
London North West Healthcare NHS Trust
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life changes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days with faecal soiling | Will be assessed every four weeks during a twenty-week period | By means of a four week bowel habit diary |
| Days with faecal urgency. | Will be assessed every four weeks during a twelve-week period | By means of a four week bowel habit diary |
| Number of incontinence episodes | 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. |
| 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 | 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. |
| Wexner incontinence score | Will be assessed every four weeks during a twenty-week period | — |
Countries
Denmark, United Kingdom
Outcome results
None listed