Status:
UNKNOWN
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
Lead Sponsor:
Uppsala University Hospital
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NAS...
Eligibility Criteria
Inclusion
- Fecal incontinence with at least 2 episodes/week
- Symptom duration at least one year
- Failed attempt of conservative therapy
- Age 18-80
- Written informed consent
- Available for follow-up
- Fully compliant with protocol
Exclusion
- Active inflammatory bowel disease
- Total external sphincter defect at ultrasound and clinical examination
- Bleeding diathesis or anticoagulant therapy
- Rectal prolapse or intussusceptions
- Present anal sepsis
- Anorectal implants
- Recent anorectal surgery (within 6 months)
- Rectal anastomosis
- Pregnancy, postpartum (one year) or breast feeding
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00971269
Start Date
January 1 2009
End Date
June 1 2011
Last Update
September 3 2009
Active Locations (1)
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1
Department of Surgery, University Hospital
751 82 Uppsala, Sweden