NCT00333073

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
5 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 17, 2014

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

June 1, 2006

Last Update Submit

February 14, 2014

Conditions

Urinary Incontinence

Keywords

urinary incontinenceBulkamid

Outcome Measures

Primary Outcomes (1)

  • Subjective responder rate after 12 months follow-up

    12 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

Bulkamid

EXPERIMENTAL

Submucosal injection of Bulkamid into urethra

Device: Bulkamid

Interventions

BulkamidDEVICE

initial injection with option for second (if required)

Bulkamid

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Symptomatic stress or mixed urinary incontinence for at least 12 months
  • Having at least 1 incontinence episode per day over three days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Skejby Sygehus

Aarhus, Denmark

Location

KAS Glostrup

Glostrup Municipality, Denmark

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

DRK Gemeinnützige Krankenhaus Gmbh

Chemnitz, Germany

Location

Karolinska Institutet

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Worthing Hospital

Worthing, West Sussex, United Kingdom

Location

Birmingham Women´s Hospital

Birmingham, United Kingdom

Location

University Hospital of Hartlepool

Hartlepool, United Kingdom

Location

St. George´s Hospital

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Lose, Prof., MD

    KAS Glostrup

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2008

Study Completion

May 1, 2010

Last Updated

February 17, 2014

Record last verified: 2013-07

Locations

DE(1)GB(4)SE(2)DK(2)FI(1)