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. 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

September 2, 2009
September 3, 2009
September 3, 2009
January 2009
December 2010   (Final data collection date for primary outcome measure)
Change in fecal incontinence episodes [ Time Frame: Follow up during a four week period and after 6 and 12 months ]
Same as current
No Changes Posted
Side effects related to treatment [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
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.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fecal Incontinence
Device: Solesta (Nasha/Dx)
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
Other Name: Solesta
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EPN 2008/066
Not Provided
Not Provided
Professor Wilhelm Graf, Dept of Surgery, Uppsala University Hospital
Uppsala University Hospital
Not Provided
Not Provided
Uppsala University Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP