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Pilot Study of NASHA/Dx Gel for Fecal Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00971269
Recruitment Status : Unknown
Verified September 2009 by Uppsala University Hospital.
Recruitment status was:  Recruiting
First Posted : September 3, 2009
Last Update Posted : September 3, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: Solesta (Nasha/Dx) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change in fecal incontinence episodes [ Time Frame: Follow up during a four week period and after 6 and 12 months ]

Secondary Outcome Measures :
  1. Side effects related to treatment [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971269

Contact: Wilhelm JR Graf, MD PhD +46(0)18 611 46 06 wilhelm.graf@akademiska.se

Department of Surgery, University Hospital Recruiting
751 82 Uppsala, Sweden
Principal Investigator: Wilhelm JR Graf, MD PhD         
Sponsors and Collaborators
Uppsala University Hospital

Responsible Party: Professor Wilhelm Graf, Dept of Surgery, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT00971269     History of Changes
Other Study ID Numbers: EPN 2008/066
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: September 3, 2009
Last Verified: September 2009

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