Status:
COMPLETED
Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
University of Tromso
Hvidovre University Hospital
Conditions:
Faecal Incontinence
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). In a selected patient group we have evidence that 90% of patie...
Detailed Description
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). The therapy is recommended by the International Continence Soci...
Eligibility Criteria
Inclusion
- ≥18 years
- Informed consent
- Idiopathic faecal incontinence or incontinence following external sphincter tear ≤ 160 degrees.
- ≥ one faecal incontinence episode after optimized conservative treatment.
- Ability to use the patient programmer.
Exclusion
- Pregnancy
- Diabetes
- Neurological diseases, including spinal cord injuries
- Pelvic irradiation
- Rectal resections
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03261622
Start Date
November 1 2016
End Date
November 1 2020
Last Update
November 2 2023
Active Locations (1)
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1
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000