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

June 27, 2011 updated by: Uppsala University Hospital
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

35

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
        • Department of Surgery, University Hospital

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

Description

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.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anal injection of Nasha Dx
Procedure: Anal injection of Nasha Dx
Submucous injection of Nasha Dx 5-10 mm above dentate line
Other Names:
  • Solesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time Frame: One year posttreatment
One year posttreatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: One year posttreatment
One year posttreatment
Global assessment
Time Frame: One year posttreatment
Graded by the patient as excellent, good, fair or poor
One year posttreatment
Change in incontinence episodes
Time Frame: One year posttreatment
Measured relative baseline based on a 4-week diary
One year posttreatment
Quality of life
Time Frame: One year posttreatment
Measured with a validated bowel function questionnaire
One year posttreatment
Adverse events
Time Frame: Two years posttreatment
Two years posttreatment
Global assessment
Time Frame: Two years posttreatment
Graded by the patient as excellent, good, fair or poor
Two years posttreatment
Change in incontinence episodes
Time Frame: Two years posttreatment
Measured relative baseline based on a 4-week diary
Two years posttreatment
Quality of life
Time Frame: Two years posttreatment
Measured with a validated bowel function questionnaire
Two years posttreatment
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time Frame: Two years posttreatment
Two years posttreatment

Collaborators and Investigators

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

Sponsor

Uppsala University Hospital

Collaborators

Galderma R&D

Investigators

  • Principal Investigator: Wilhelm JR Graf, Prof., Inst of Surgical Sciences, Uppsala university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2004

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nasha Dx Pilot study
  • 03 464 (OTHER: EPN Uppsala)

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 Anal injection of Nasha Dx

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe