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

Contura

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Bulkamid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333073

CONSUI-EU02

Details and patient eligibility

About

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

Enrollment: 125 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Bulkamid

Experimental group

Description:

Submucosal injection of Bulkamid into urethra

Treatment:

Device: Bulkamid