Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Contura
ClinicalTrials.gov Identifier:
NCT00629083
First received: February 26, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention
Stress Urinary Incontinence
Device: Bulkamid
Device: Contigen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Contura:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of device- and procedure-related serious adverse events through 12 months follow-up. [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 24hr Pad Test [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Subject Perception of Effectiveness [ Time Frame: 3, 6. 9 and 12 months ] [ Designated as safety issue: No ]
  • IQoL [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • ICIQ-UI Short Form [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 345
Study Start Date: April 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bulkamid Hydrogel injection
Device: Bulkamid
Bulking injection with Bulkamid injection device
Active Comparator: 2
Contigen injection
Device: Contigen
Transurethral bulking injection

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629083

  Show 34 Study Locations
Sponsors and Collaborators
Contura
Investigators
Study Director: Silvia Garcia-Codony Contura
  More Information

No publications provided

Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT00629083     History of Changes
Other Study ID Numbers: CONSUI-US01
Study First Received: February 26, 2008
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Contura:
SUI
Bulkamid
Urinary Incontinence

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

ClinicalTrials.gov processed this record on July 31, 2014