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

Not Applicable

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT00333073
• Lead Sponsor: Contura

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2008-10
• Study Completion: 2010-05
• Status Verified: 2013-07
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective responder rate after 12 months follow-up	12 months

Secondary Outcome Measures

Name	Time	Method
ICIQ	Baseline, treatment, 1-, 6-, 12- and 24-months
24 hour urine leakage	Baseline, treatment, 1-, 6-, 12- and 24-months
daily incidence of incontinence episodes	Baseline, treatment, 1-, 6-, 12- and 24-months
Qol	Baseline, treatment, 1-, 6-, 12- and 24-months

Trial Locations

Locations (10)

Skejby Sygehus; 🇩🇰 Aarhus, Denmark

KAS Glostrup; 🇩🇰 Glostrup, Denmark

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

DRK Gemeinnützige Krankenhaus Gmbh; 🇩🇪 Chemnitz, Germany

Karolinska Institutet; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden

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