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

This study has been completed.
Sponsor:
Collaborator:
Q-Med AB
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01380132
First received: June 21, 2011
Last updated: June 27, 2011
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Fecal Incontinence
Procedure: Anal injection of Nasha Dx
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Treatment response as measured by a 50% reduction in no of incontinence episodes. [ Time Frame: One year posttreatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: One year posttreatment ] [ Designated as safety issue: Yes ]
  • Global assessment [ Time Frame: One year posttreatment ] [ Designated as safety issue: No ]
    Graded by the patient as excellent, good, fair or poor

  • Change in incontinence episodes [ Time Frame: One year posttreatment ] [ Designated as safety issue: No ]
    Measured relative baseline based on a 4-week diary

  • Quality of life [ Time Frame: One year posttreatment ] [ Designated as safety issue: No ]
    Measured with a validated bowel function questionnaire

  • Adverse events [ Time Frame: Two years posttreatment ] [ Designated as safety issue: Yes ]
  • Global assessment [ Time Frame: Two years posttreatment ] [ Designated as safety issue: No ]
    Graded by the patient as excellent, good, fair or poor

  • Change in incontinence episodes [ Time Frame: Two years posttreatment ] [ Designated as safety issue: No ]
    Measured relative baseline based on a 4-week diary

  • Quality of life [ Time Frame: Two years posttreatment ] [ Designated as safety issue: No ]
    Measured with a validated bowel function questionnaire

  • Treatment response as measured by a 50% reduction in no of incontinence episodes. [ Time Frame: Two years posttreatment ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: February 2004
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anal injection of Nasha Dx Procedure: Anal injection of Nasha Dx
Submucous injection of Nasha Dx 5-10 mm above dentate line
Other Name: Solesta

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380132

Locations
Sweden
Department of Surgery, University Hospital
751 82 Uppsala, Sweden
Sponsors and Collaborators
Uppsala University Hospital
Q-Med AB
Investigators
Principal Investigator: Wilhelm JR Graf, Prof. Inst of Surgical Sciences, Uppsala university
  More Information

Publications:
Responsible Party: Olof Nilsson, Uppsala university
ClinicalTrials.gov Identifier: NCT01380132     History of Changes
Other Study ID Numbers: Nasha Dx Pilot study, 03 464
Study First Received: June 21, 2011
Last Updated: June 27, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Uppsala University Hospital:
Fecal incontinence
Treatment
Surgery

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014