Pilot Study of NASHA/Dx Gel for Fecal Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Uppsala University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT00971269
First received: September 2, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention Phase
Fecal Incontinence
Device: Solesta (Nasha/Dx)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Change in fecal incontinence episodes [ Time Frame: Follow up during a four week period and after 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects related to treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00971269

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

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

No publications provided

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
Study First Received: September 2, 2009
Last Updated: September 2, 2009
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on August 28, 2014