Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00971269
• Other study ID #: EPN 2008/066
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 2, 2009
• Last updated: September 2, 2009
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2009
• Source: Uppsala University Hospital
• Contact: Wilhelm JR Graf, MD PhD
• Phone: +46(0)18 611 46 06
• Email: wilhelm.graf[@]akademiska.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Solesta (Nasha/Dx)
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks

Locations

Country	Name	City	State
Sweden	Department of Surgery, University Hospital	751 82 Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fecal incontinence episodes		Follow up during a four week period and after 6 and 12 months	No
Secondary	Side effects related to treatment		12 months	Yes