Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629083
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):

Brief Summary:
The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Bulkamid Device: Contigen Not Applicable

Detailed Description:

The study is a single-masked, randomized, comparative multi-center, 2-arm parallel study intended to demonstrate the safety and effectiveness of Bulkamid® vs. Contigen® for the treatment of stress urinary incontinence (SUI)due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.

Subjects will be randomized to receive either a polyacrylamide hydrogel (Bulkamid®) treatment, or a collagen treatment (Contigen®) using a 2:1 ratio and will be masked to the treatment. Screening baseline evaluations and collagen skin testing will be completed to determine eligible subjects. Following a negative skin test, a subject will be randomized and treated with Bulkamid® or the comparator device at the Treatment Visit.

Subjects that are not continent will be considered for re-injection. A maximum of 3 injections (initial + 2 re-injections) are allowed. After the last injection, subjects will attend the 3-Month, 6-Month and 12-Month Follow-up Visits plus a telephone contact at 9 months.

The study will record objective incontinence measurements, subject's perception of effectiveness and quality of life assessments. Adverse events will be recorded throughout the study.

Each subject will be followed for 12 months from the last injection.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Bulkamid Hydrogel injection
Device: Bulkamid
Bulking injection with Bulkamid injection device
Active Comparator: 2
Contigen injection
Device: Contigen
Transurethral bulking injection

Primary Outcome Measures :
  1. Proportion of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and Daily number of incontinence episodes [ Time Frame: 12 Months ]
  2. Incidence of device- and procedure-related serious adverse events through 12 months follow-up. [ Time Frame: Baseline through 12 months ]

Secondary Outcome Measures :
  1. 24hr Pad Test [ Time Frame: Baseline, 3, 6 and 12 months ]
  2. Subject Perception of Effectiveness [ Time Frame: 3, 6. 9 and 12 months ]
  3. IQoL [ Time Frame: Baseline, 3, 6 and 12 months ]
  4. ICIQ-UI Short Form [ Time Frame: Baseline, 3, 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629083

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Sponsors and Collaborators
Study Director: Silvia Garcia-Codony Contura

Responsible Party: Contura Identifier: NCT00629083     History of Changes
Other Study ID Numbers: CONSUI-US01
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: February 2015

Keywords provided by Contura:
Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders