Status:
COMPLETED
Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stim...
Eligibility Criteria
Inclusion
- fecal incontinence, refractory to medical treatment,for more than 3 months,with at least one episode of anal incontinence and/or urgency per month
- patient with no knowledge of cutaneous stimulation
- patients with NHS
Exclusion
- older than 18 years old
- pregnancy
- implanted stimulator
- cutaneous lesion
- cutaneous anesthesia
- patients without oral contraception
- Guardianship and curatorship
- fecal incontinence secondary to anorectal malformation, surgical sequelae, significative sphincteric lesion leading to repair at a first time, rectal prolapse, active neurological disease
- patient already treated by sacral nerve stimulation or stimulated graciloplasty, artificial bowel sphincter, radiofrequency
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00977652
Start Date
October 1 2009
End Date
June 1 2011
Last Update
August 23 2011
Active Locations (1)
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1
Leroi
Rouen, France, 76000