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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bulkamid

Submucosal injection of Bulkamid into urethra

Group Type EXPERIMENTAL

Bulkamid

Intervention Type DEVICE

initial injection with option for second (if required)

Interventions

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Bulkamid

initial injection with option for second (if required)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No