Stem Cell therapy on human Fecal incontinence
Phase 2
Recruiting
- Conditions
- Faecal incontinence.Fecal incontinence
- Registration Number
- IRCT20160201026316N4
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Age?>25 years
Wexner score?=?8
Confirmation of external anal sphincter defect with endorectal ultrasonography
Patient consent for inclusion
Exclusion Criteria
Pregnancy and breastfeeding
Participating in other trials within the past 30 days
History of artificial sphincter
Vaginal delivery within the past 6 months
Presence of chronic diseases
Autoimmune disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wexner Score. Timepoint: 2 months after intervention. Method of measurement: Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history).;Rate of wound closure. Timepoint: Immediately after surgery to wound closure. Method of measurement: Experienced surgeon view.
- Secondary Outcome Measures
Name Time Method External anal sphincter action potential record in the defect site. Timepoint: Two months after intervention. Method of measurement: Electromyography.;External anal sphincter morphology. Timepoint: Two months after intervention. Method of measurement: Endorectal Sonography.;Amount of muscle in the external anal sphincter defect site. Timepoint: Two months after intervention. Method of measurement: Image J software.