Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Phase 1

• Conditions: Fecal Incontinence

• Registration Number: NCT00971269
• Lead Sponsor: Uppsala University Hospital

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 NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Last Update Submitted: 2009-09-02
• Study First Posted: 2009-09-03
• Last Update Posted: 2009-09-03
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol

Exclusion Criteria

1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in fecal incontinence episodes	Follow up during a four week period and after 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Side effects related to treatment	12 months

Trial Locations

Locations (1)

Department of Surgery, University Hospital; 🇸🇪 751 82 Uppsala, Sweden