CClinicalTrials.gg
Sign In
CompletedNCT00333073Updated Feb 17, 2014

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

An interventional study of Bulkamid in Urinary Incontinence, sponsored by Contura. Completed at 10 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-17.

Sponsored by Contura · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Urinary Incontinence

Keywords

  • urinary incontinence
  • Bulkamid
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 125 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Contura is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Experimental
    Bulkamid

    Submucosal injection of Bulkamid into urethra

    Device: Bulkamid

Interventions

  • DeviceBulkamid

    initial injection with option for second (if required)

06

What researchers measure

Primary outcomes

  1. Subjective responder rate after 12 months follow-up

    Time frame: 12 months

Secondary outcomes

  1. ICIQ

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  2. 24 hour urine leakage

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  3. daily incidence of incontinence episodes

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  4. Qol

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

07

Study locations

10 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00333073
Lead sponsor
Contura
Responsible party
Sponsor
First posted
Jun 2, 2006
Start date
Mar 2006
Primary completion
Oct 2008
Completion
May 2010
Last update
Feb 17, 2014

Study contacts

Gunnar Lose, Prof., MD
principal investigator · KAS Glostrup
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Incontinence→

Other studies from this sponsor

Contura

Start the discussion