Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380132
• Other study ID #: Nasha Dx Pilot study
• Secondary ID: 03 464
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 21, 2011
• Last updated: June 27, 2011
• Start date: February 2004
• Est. completion date: May 2009

Study information

• Verified date: February 2010
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Description:

Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).

• Age 18-80

• Available for follow-up for the duration of the study

• Written informed consent.

Exclusion Criteria:

• Sphincter defect visible on anal ultrasound.

• Pregnancy.

• Rectal prolapse or inflammatory bowel disease.

• Recent (within 6 months) anal surgery except for haemorrhoids.

• Anorectal sepsis.

• Anticoagulant medication or bleeding diathesis.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• Anal injection of Nasha Dx
Submucous injection of Nasha Dx 5-10 mm above dentate line

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Q-Med AB

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response as measured by a 50% reduction in no of incontinence episodes.		One year posttreatment	No
Secondary	Adverse events		One year posttreatment	Yes
Secondary	Global assessment	Graded by the patient as excellent, good, fair or poor	One year posttreatment	No
Secondary	Change in incontinence episodes	Measured relative baseline based on a 4-week diary	One year posttreatment	No
Secondary	Quality of life	Measured with a validated bowel function questionnaire	One year posttreatment	No
Secondary	Adverse events		Two years posttreatment	Yes
Secondary	Global assessment	Graded by the patient as excellent, good, fair or poor	Two years posttreatment	No
Secondary	Change in incontinence episodes	Measured relative baseline based on a 4-week diary	Two years posttreatment	No
Secondary	Quality of life	Measured with a validated bowel function questionnaire	Two years posttreatment	No
Secondary	Treatment response as measured by a 50% reduction in no of incontinence episodes.		Two years posttreatment	No