Effectiveness and Safety of Bulkamid® as Bulking Agent fo... | NCT00333073

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

NCT00333073

Sponsor

Contura

Status

Completed

Last Update Posted

Feb 17, 2014Estimated

Enrollment

125Actual

Phase

Not Applicable

Conditions

Urinary Incontinence

Interventions

Bulkamid

Countries

Denmark
Finland
Germany
Sweden
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Oct 2008Actual

Completion Date

May 2010Actual

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2014

Last Update Posted Date

Feb 17, 2014Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bulkamid	Experimental	Submucosal injection of Bulkamid into urethra	Device: Bulkamid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bulkamid	Device	initial injection with option for second (if required)	Bulkamid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective responder rate after 12 months follow-up		12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Lose, Prof., MD	KAS Glostrup	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skejby Sygehus		Aarhus			Denmark
KAS Glostrup

Label	URL
Bulkamid Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided