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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bulkamid
Sponsored by
Contura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, Bulkamid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Skejby Sygehus
  • KAS Glostrup
  • Helsinki University Central Hospital
  • DRK Gemeinnützige Krankenhaus Gmbh
  • Karolinska Institutet
  • Södersjukhuset
  • Worthing Hospital
  • Birmingham Women´s Hospital
  • University Hospital of Hartlepool
  • St. George´s Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bulkamid

Arm Description

Submucosal injection of Bulkamid into urethra

Outcomes

Primary Outcome Measures

Subjective responder rate after 12 months follow-up

Secondary Outcome Measures

ICIQ
24 hour urine leakage
daily incidence of incontinence episodes
Qol

Full Information

First Posted
June 1, 2006
Last Updated
February 14, 2014
Sponsor
Contura
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1. Study Identification

Unique Protocol Identification Number
NCT00333073
Brief Title
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Official Title
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contura

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, Bulkamid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bulkamid
Arm Type
Experimental
Arm Description
Submucosal injection of Bulkamid into urethra
Intervention Type
Device
Intervention Name(s)
Bulkamid
Intervention Description
initial injection with option for second (if required)
Primary Outcome Measure Information:
Title
Subjective responder rate after 12 months follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ICIQ
Time Frame
Baseline, treatment, 1-, 6-, 12- and 24-months
Title
24 hour urine leakage
Time Frame
Baseline, treatment, 1-, 6-, 12- and 24-months
Title
daily incidence of incontinence episodes
Time Frame
Baseline, treatment, 1-, 6-, 12- and 24-months
Title
Qol
Time Frame
Baseline, treatment, 1-, 6-, 12- and 24-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Lose, Prof., MD
Organizational Affiliation
KAS Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skejby Sygehus
City
Aarhus
Country
Denmark
Facility Name
KAS Glostrup
City
Glostrup
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
DRK Gemeinnützige Krankenhaus Gmbh
City
Chemnitz
Country
Germany
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Worthing Hospital
City
Worthing
State/Province
West Sussex
Country
United Kingdom
Facility Name
Birmingham Women´s Hospital
City
Birmingham
Country
United Kingdom
Facility Name
University Hospital of Hartlepool
City
Hartlepool
Country
United Kingdom
Facility Name
St. George´s Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bulkamid.com/
Description
Bulkamid Website

Learn more about this trial

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

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