Urinary IncontinenceNCT00333073
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
A study testing Bulkamid in people with Urinary Incontinence, run by Contura at 10 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Bulkamid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Mar 2006to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Symptomatic stress or mixed urinary incontinence for at least 12 months
- Having at least 1 incontinence episode per day over three days
Who cannot join
- 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
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United Kingdom4 sites
Birmingham Women´s Hospital
Birmingham
University Hospital of Hartlepool
Hartlepool
St. George´s Hospital
London
Worthing Hospital
Worthing, West Sussex
About this study
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period
- Conditions
- Urinary Incontinence
- Being tested
- Bulkamid
- Keywords
- urinary incontinence, Bulkamid
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulkamidDevice
initial injection with option for second (if required)
| Study group | Role | What they receive |
|---|---|---|
| Bulkamid | Experimental | Submucosal injection of Bulkamid into urethra Receives: Device: Bulkamid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective responder rate after 12 months follow-up
Measured: 12 months
Secondary outcomes (4)
ICIQ
Measured: Baseline, treatment, 1-, 6-, 12- and 24-months
24 hour urine leakage
Measured: Baseline, treatment, 1-, 6-, 12- and 24-months
daily incidence of incontinence episodes
Measured: Baseline, treatment, 1-, 6-, 12- and 24-months
Qol
Measured: Baseline, treatment, 1-, 6-, 12- and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Lose, Prof., MD, Principal investigator, KAS Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333073
- Sponsor's protocol ID
- CONSUI-EU02
- Status last verified
- Jul 2013
- First submitted
- 1 Jun 2006
- Last updated
- 17 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00333073
- Acronym / sponsor ID
- CONSUI-EU02
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, Bulkamid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- ConturaIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bulkamid | Experimental | Device: BulkamidSubmucosal injection of Bulkamid into urethra |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Symptomatic stress or mixed urinary incontinence for at least 12 months
- Having at least 1 incontinence episode per day over three days
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulkamidinitial injection with option for second (if required) | Device | Bulkamid |
Primary outcome
Subjective responder rate after 12 months follow-up
Time frame: 12 months
4 secondary outcomes
ICIQ
Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months
24 hour urine leakage
Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months
daily incidence of incontinence episodes
Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Qol
Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Bulkamid WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Lose, Prof., MD principal investigator
KAS Glostrup
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulkamid in people with Urinary Incontinence, run by Contura at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Denmark, Sweden, Finland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective responder rate after 12 months follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.