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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Anal injection of Nasha Dx
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Treatment, Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anal injection of Nasha Dx

Arm Description

Outcomes

Primary Outcome Measures

Treatment response as measured by a 50% reduction in no of incontinence episodes.

Secondary Outcome Measures

Adverse events
Global assessment
Graded by the patient as excellent, good, fair or poor
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Quality of life
Measured with a validated bowel function questionnaire
Adverse events
Global assessment
Graded by the patient as excellent, good, fair or poor
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Quality of life
Measured with a validated bowel function questionnaire
Treatment response as measured by a 50% reduction in no of incontinence episodes.

Full Information

First Posted
June 21, 2011
Last Updated
June 27, 2011
Sponsor
Uppsala University Hospital
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01380132
Brief Title
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Official Title
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Uppsala University Hospital
Collaborators
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
Detailed Description
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal incontinence, Treatment, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anal injection of Nasha Dx
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Anal injection of Nasha Dx
Other Intervention Name(s)
Solesta
Intervention Description
Submucous injection of Nasha Dx 5-10 mm above dentate line
Primary Outcome Measure Information:
Title
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time Frame
One year posttreatment
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
One year posttreatment
Title
Global assessment
Description
Graded by the patient as excellent, good, fair or poor
Time Frame
One year posttreatment
Title
Change in incontinence episodes
Description
Measured relative baseline based on a 4-week diary
Time Frame
One year posttreatment
Title
Quality of life
Description
Measured with a validated bowel function questionnaire
Time Frame
One year posttreatment
Title
Adverse events
Time Frame
Two years posttreatment
Title
Global assessment
Description
Graded by the patient as excellent, good, fair or poor
Time Frame
Two years posttreatment
Title
Change in incontinence episodes
Description
Measured relative baseline based on a 4-week diary
Time Frame
Two years posttreatment
Title
Quality of life
Description
Measured with a validated bowel function questionnaire
Time Frame
Two years posttreatment
Title
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time Frame
Two years posttreatment

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm JR Graf, Prof.
Organizational Affiliation
Inst of Surgical Sciences, Uppsala university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University Hospital
City
751 82 Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19581853
Citation
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.
Results Reference
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Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

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