Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
1 other identifier
interventional
15
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 3, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 10, 2011
November 1, 2011
8 months
December 3, 2010
November 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Number of incontinence episodes
Will be assessed every four weeks durring a twenty-week period
Days with faecal soiling
Will be assessed every four weeks during a twenty-week period
Days with faecal urgency.
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
- +1 more secondary outcomes
Study Arms (5)
Standard settings
ACTIVE COMPARATORAmplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec
Experimental Setting 1
EXPERIMENTALAmplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec
Experimental setting 2
EXPERIMENTALAmplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec
Experimental setting 3
EXPERIMENTALAmplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec
Experimental setting 4
EXPERIMENTALAmplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec
Interventions
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- London North West Healthcare NHS Trustcollaborator
Study Sites (2)
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8200, Denmark
St. Marks Hospital
London, Harrow - Middlesex, HA1 3UJ, United Kingdom
Related Publications (1)
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.
PMID: 22961528DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakob k Jakobsen, MD.
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2010
First Posted
December 6, 2010
Study Start
July 1, 2010
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
November 10, 2011
Record last verified: 2011-11