Clinical trial NCT01254695: Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
Official title: Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Idiopathic Fecal Incontinence
Fecal Incontinence
Sacral Nerve Stimulation
Sacral Nerve Neuromodulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: London North West Healthcare NHS Trust
First posted: 2010-12-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life changes
timeFrame: Will be assessed every four weeks during a twenty-week period
Secondary outcomes:
measure: Number of incontinence episodes
timeFrame: Will be assessed every four weeks durring a twenty-week period
measure: Days with faecal soiling
timeFrame: Will be assessed every four weeks during a twenty-week period
measure: Days with faecal urgency.
timeFrame: Will be assessed every four weeks during a twelve-week period
measure: Wexner incontinence score
timeFrame: Will be assessed every four weeks during a twenty-week period
measure: St. Marks Incontinence score
timeFrame: Will be assessed every four weeks during a twenty-week period
measure: Assess changes in anorectal volume and pressure with different pacemaker settings
timeFrame: Will be assessed every four weeks during a twenty-week period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
state: Aarhus C
city: London
country: United Kingdom
facility: St. Marks Hospital
state: Harrow - Middlesex
Study officials:
affiliation: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
name: Jakob k Jakobsen, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.