Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Contura
ClinicalTrials.gov Identifier:
NCT00333073
First received: June 1, 2006
Last updated: February 14, 2014
Last verified: July 2013
  Purpose

To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period


Condition Intervention
Urinary Incontinence
Device: Bulkamid

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Contura:

Primary Outcome Measures:
  • Subjective responder rate after 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICIQ [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • 24 hour urine leakage [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • daily incidence of incontinence episodes [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • Qol [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: March 2006
Study Completion Date: May 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bulkamid
Submucosal injection of Bulkamid into urethra
Device: Bulkamid
initial injection with option for second (if required)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00333073

Locations
Denmark
Skejby Sygehus
Aarhus, Denmark
KAS Glostrup
Glostrup, Denmark
Finland
Helsinki University Central Hospital
Helsinki, Finland
Germany
DRK Gemeinnützige Krankenhaus Gmbh
Chemnitz, Germany
Sweden
Karolinska Institutet
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
United Kingdom
Worthing Hospital
Worthing, West Sussex, United Kingdom
Birmingham Women´s Hospital
Birmingham, United Kingdom
University Hospital of Hartlepool
Hartlepool, United Kingdom
St. George´s Hospital
London, United Kingdom
Sponsors and Collaborators
Contura
Investigators
Principal Investigator: Gunnar Lose, Prof., MD KAS Glostrup
  More Information

Additional Information:
No publications provided

Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT00333073     History of Changes
Other Study ID Numbers: CONSUI-EU02
Study First Received: June 1, 2006
Last Updated: February 14, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Sweden: Regional Ethical Review Board
Germany: Ethics Commission
Finland: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Contura:
urinary incontinence
Bulkamid

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014