Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Bulkamid; Device: Contigen

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
• Enrollment (Actual): 345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 5G1
      • Can-Med Clinical Research, Inc.
    • Victoria, British Columbia, Canada, V8V3N1
      • Gary Steinhoff Clinical Research
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • University of Sherbrooke
• France
  • Paris, France, 75020
    • Hôpital Tenon
• United States
  • California
    • Encinitas, California, United States, 92024
      • Incontinence Research Institute
    • Los Angeles, California, United States, 90048
      • Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
    • Oxnard, California, United States, 93030
      • Sherif Aboseif, MD
    • Pasadena, California, United States, 91101
      • South California Permanente Medical Group
    • Stanford, California, United States, 94305
      • Stanford UniveritySchool of Medicine - Departmert of OB/GYN
  • Colorado
    • Denver, Colorado, United States, 80220
      • Genitourinary Surgical Consultants
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Department of Urology
    • Miami, Florida, United States, 33136
      • University of Miami and Jackson Memorial Hospital
    • Naples, Florida, United States, 34102
      • Specialists in Urology
    • Winter Haven, Florida, United States, 33881
      • Discovery Clinical Trials
  • Illinois
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic
    • New Orleans, Louisiana, United States, 70122
      • LSU Health Science Center
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Urology
  • New York
    • Albany, New York, United States, 12205
      • Northeast Urogynecology
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • West Chester, Ohio, United States, 45069
      • Midwest Institute for Research & Education
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • St. Lukes Hospital and Health Network
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina - Department of Urology
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas - Department of Urology
    • Houston, Texas, United States, 77030
      • Vanguard Urologic Research Foundation
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Vermont
    • Burlington, Vermont, United States, 05403
      • University of Vermont - The Continence Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virgina Mason Medical Center - Section of Urology and Renal Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	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	12 Months
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.	The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr Pad Test	A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.	12 months
Number of Subjects Reporting as a Responder	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.	12 months
IQoL	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.	12 months
ICIQ-UI Short Form	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).	12 months
Number of Incontinence Episodes	The total number of incontinence episodes experienced by the subject over three consecutive days.	12 months

Collaborators and Investigators

• Sponsor: Contura
• Collaborators: Regulatory and Clinical Research Institute (RCRI)
• Investigators: Study Director: Silvia Garcia-Codony, Contura

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Urinary Incontinence; Bulkamid; SUI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CONSUI-US01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes