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NCT00333073 Clinical Trial

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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333073
Other study ID # CONSUI-EU02
Secondary ID
Status Completed
Phase N/A
First received June 1, 2006
Last updated February 14, 2014
Start date March 2006
Est. completion date May 2010

Study information
Verified date July 2013
Source Contura
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsSweden: Regional Ethical Review BoardGermany: Ethics CommissionFinland: Ethics CommitteeUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date May 2010
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bulkamid
initial injection with option for second (if required)

Locations
Country Name City State
Denmark Skejby Sygehus Aarhus
Denmark KAS Glostrup Glostrup
Finland Helsinki University Central Hospital Helsinki
Germany DRK Gemeinnützige Krankenhaus Gmbh Chemnitz
Sweden Karolinska Institutet Stockholm
Sweden Södersjukhuset Stockholm
United Kingdom Birmingham Women´s Hospital Birmingham
United Kingdom University Hospital of Hartlepool Hartlepool
United Kingdom St. George´s Hospital London
United Kingdom Worthing Hospital Worthing West Sussex

Sponsors (1)
Lead Sponsor Collaborator
Contura

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective responder rate after 12 months follow-up 12 months No
Secondary ICIQ Baseline, treatment, 1-, 6-, 12- and 24-months No
Secondary 24 hour urine leakage Baseline, treatment, 1-, 6-, 12- and 24-months No
Secondary daily incidence of incontinence episodes Baseline, treatment, 1-, 6-, 12- and 24-months No
Secondary Qol Baseline, treatment, 1-, 6-, 12- and 24-months No
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