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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
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Regulatory and Clinical Research Institute (RCRI)
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.

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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
Actual 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

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. Primary Effectiveness Endpoint [ Time Frame: 12 Months ]
    The number 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

  2. The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up. [ Time Frame: 12 months ]
    The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.

Secondary Outcome Measures :
  1. 24hr Pad Test [ Time Frame: 12 months ]
    A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.

  2. Number of Subjects Reporting as a Responder [ Time Frame: 12 months ]
    At the 12-month primary endpoint follow-up visit, the subject was asked to provide her perception of treatment effectiveness by circling the most accurate description of her condition: cured/dry; much improved; improved; no change; worse. The response was dichotomized into responder or non-responder. A subject was classified as a responder if she reported that the treatment had cured, much improved, or improved her incontinence condition.

  3. IQoL [ Time Frame: 12 months ]
    The IQoL is a validated instrument consisting of 22 questions grouped into three subscales: avoidance and limiting behaviors; psychosocial impacts, and social embarrassment. It is a subject self-reported quality-of-life measure specific to urinary problems that is used to assess the impact of urinary incontinence and urinary problems and their treatment. The subject scores each question on a scale of 1 to 5 with higher scores indicating more positive responses. The maximum score was 110 points and the minimum score was 22.

  4. ICIQ-UI Short Form [ Time Frame: 12 months ]
    The ICIQ-UI Short Form assesses the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire consists of three questions with a maximum score of 21 and a minimum score of zero (0). A lower score represents a decrease in the severity of symptoms (i.e., improvement).

  5. Number of Incontinence Episodes [ Time Frame: 12 months ]
    The total number of incontinence episodes experienced by the subject over three consecutive days.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Regulatory and Clinical Research Institute (RCRI)
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Study Director: Silvia Garcia-Codony Contura
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Responsible Party: Contura Identifier: NCT00629083    
Other Study ID Numbers: CONSUI-US01
First Posted: March 5, 2008    Key Record Dates
Results First Posted: February 7, 2020
Last Update Posted: February 7, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Contura:
Urinary Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders