Status:
COMPLETED
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
London North West Healthcare NHS Trust
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01254695
Start Date
July 1 2010
End Date
June 1 2011
Last Update
November 10 2011
Active Locations (2)
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1
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8200
2
St. Marks Hospital
London, Harrow - Middlesex, United Kingdom, HA1 3UJ