Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

February 14, 2014 updated by: Contura
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

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

  • Denmark
      • Aarhus, Denmark
        • Skejby Sygehus
      • Glostrup, Denmark
        • KAS Glostrup
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
  • Germany
      • Chemnitz, Germany
        • DRK Gemeinnützige Krankenhaus Gmbh
  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet
      • Stockholm, Sweden
        • Södersjukhuset
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Women´s Hospital
      • Hartlepool, United Kingdom
        • University Hospital of Hartlepool
      • London, United Kingdom
        • St. George´s Hospital
    • West Sussex
      • Worthing, West Sussex, United Kingdom
        • Worthing 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent
  • Symptomatic stress or mixed urinary incontinence for at least 12 months
  • Having at least 1 incontinence episode per day over three days

Exclusion Criteria:

  • Regular or intermittent users of an urethral catheter
  • Pregnant women
  • Suffer from severe allergies or anaphylaxis
  • Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
  • History of any cancer within the last 5 years
  • Previous surgery for the treatment of urinary incontinence, including bulking

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bulkamid
Submucosal injection of Bulkamid into urethra
Device: Bulkamid
initial injection with option for second (if required)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective responder rate after 12 months follow-up
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ICIQ
Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Baseline, treatment, 1-, 6-, 12- and 24-months
24 hour urine leakage
Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Baseline, treatment, 1-, 6-, 12- and 24-months
daily incidence of incontinence episodes
Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Baseline, treatment, 1-, 6-, 12- and 24-months
Qol
Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Baseline, treatment, 1-, 6-, 12- and 24-months

Collaborators and Investigators

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

Sponsor

Contura

Investigators

  • Principal Investigator: Gunnar Lose, Prof., MD, KAS Glostrup

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.

Helpful Links

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

March 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONSUI-EU02

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.

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