Pilot Study of NASHA/Dx Gel for Fecal Incontinence
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ClinicalTrials.gov Identifier: NCT00971269
Recruitment Status : Unknown
Verified September 2009 by Uppsala University Hospital. Recruitment status was: Recruiting
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 NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Fecal incontinence with at least 2 episodes/week
Symptom duration at least one year
Failed attempt of conservative therapy
Written informed consent
Available for follow-up
Fully compliant with protocol
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
Recent anorectal surgery (within 6 months)
Pregnancy, postpartum (one year) or breast feeding