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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00629083 |
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Date of registration:
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26/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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Scientific title:
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A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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345 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00629083 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Canada
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France
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United States
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Contacts
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Name:
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Silvia Garcia-Codony |
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Address:
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Telephone:
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Email:
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Affiliation:
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Contura |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be female 18 or more years of age.
- Females of childbearing potential or <2 years post-menopausal must be using 2 forms of
contraception.
- Suffer from SUI for at least 6 months.
- Have failed 2 previous non-invasive therapies for 3 months each.
- Have at least 3 incontinence episodes measured over 3 days.
- Have a baseline 24h pad test weight greater than or equal to 5 gm.
- Have VLPP = 100 cm H2O.
- Have maximum cystometric capacity equal or higher than (=) 250 mL.
- Have PVR urine = 100 mL.
- Have a life expectancy of more than 2 years.
Exclusion Criteria:
- Has urethral hypermobility >30 deg.
- Has predominant urge incontinence.
- Has detrusor overactivity.
- Regularly or intermittently users of urethral catheter.
- Has had previous radiation treatment in the pelvic floor.
- Has had previous urethral surgery (i.e. fistula, diverticula)or urethral bulking.
Failed sling or colposuspension procedure for at least 6 months may be included.
- Suffers from known polyuria.
- Has had three (3) or more culture-proven bacterial UTIs in the last 12 months.
- Has a current infection (urethritis, cystitis or vaginitis).
- Has unevaluated hematuria.
- Has a Prolapse Stage greater than II.
- Has a BMI>35 kg/m2.
- Is taking pharmacological treatment for stress urinary incontinence, 4 weeks prior to
screening.
- Is allergic to bovine collagen.
- Is known to suffer from severe allergies or anaphylaxis.
- Suffers from autoimmune diseases (e.e. connective tissue diseases) that could confound
the treatment.
- Is currently taking or has taken systemic corticosteroids within the past 3 months.
- Currently has cancer or has a history of any cancer within the past 5 years (skin
cancer with no evidence of skin malignancy, for at least 2 years, can be included).
- Currently suffering from unstable cardiovascular disease, cancer or uncontrolled
diabetes.
- Has active herpes genitalis.
- Is currently participating in any other clinical trial or has participated in another
clinical trial within 3 months of screening/baseline visit.
- Is pregnant, lactating or intending to become pregnant.
- Is not physically able to perform study procedure.
- Has a neurogenic bladder
- Had a vaginal delivery within 3 months prior to screening.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Stress Urinary Incontinence
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Intervention(s)
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Device: Contigen
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Device: Bulkamid
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Primary Outcome(s)
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The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
[Time Frame: 12 months]
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Primary Effectiveness Endpoint
[Time Frame: 12 Months]
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Secondary Outcome(s)
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Number of Subjects Reporting as a Responder
[Time Frame: 12 months]
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ICIQ-UI Short Form
[Time Frame: 12 months]
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Number of Incontinence Episodes
[Time Frame: 12 months]
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24hr Pad Test
[Time Frame: 12 months]
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IQoL
[Time Frame: 12 months]
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Secondary ID(s)
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CONSUI-US01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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