Status:
COMPLETED
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Lead Sponsor:
Contura
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00333073
Start Date
March 1 2006
End Date
May 1 2010
Last Update
February 17 2014
Active Locations (10)
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1
Skejby Sygehus
Aarhus, Denmark
2
KAS Glostrup
Glostrup Municipality, Denmark
3
Helsinki University Central Hospital
Helsinki, Finland
4
DRK Gemeinnützige Krankenhaus Gmbh
Chemnitz, Germany