Pilot Study of NASHA/Dx Gel for Fecal Incontinence

September 2, 2009 updated by: Uppsala University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fecal incontinence episodes
Time Frame: Follow up during a four week period and after 6 and 12 months
Follow up during a four week period and after 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects related to treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2009

Last Update Submitted That Met QC Criteria

September 2, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN 2008/066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fecal Incontinence

Clinical Trials on Solesta (Nasha/Dx)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe