Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Bulkamid; Device: Contigen

• Registration Number: NCT00629083
• Lead Sponsor: Contura

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

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 Timeline

• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-05
• Study Start: 2008-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2015-02-06
• Disposition First Submitted QC: 2015-02-06
• Disposition First Posted: 2015-02-25
• Status Verified: 2019-12
• Results First Submitted: 2019-12-02
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-07
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 345

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bulkamid	Bulkamid Hydrogel injection
2	Contigen	Contigen injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
24hr Pad Test	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.
Number of Subjects Reporting as a Responder	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.
IQoL	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.
Number of Incontinence Episodes	12 months	The total number of incontinence episodes experienced by the subject over three consecutive days.
ICIQ-UI Short Form	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).

Trial Locations

Locations (34)

Northeast Urogynecology; 🇺🇸 Albany, New York, United States

University of Vermont - The Continence Center; 🇺🇸 Burlington, Vermont, United States

University of Miami and Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

The Urology Group; 🇺🇸 Cincinnati, Ohio, United States

Mayo Clinic - Department of Urology; 🇺🇸 Jacksonville, Florida, United States

Specialists in Urology; 🇺🇸 Naples, Florida, United States

Michigan Urology; 🇺🇸 Troy, Michigan, United States

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Can-Med Clinical Research, Inc.; 🇨🇦 Victoria, British Columbia, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University of Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Hopital Tenon; 🇫🇷 Paris, France

Incontinence Research Institute; 🇺🇸 Encinitas, California, United States

Stanford UniveritySchool of Medicine - Departmert of OB/GYN; 🇺🇸 Stanford, California, United States

Tower Urology - Institute for Continence - Cedars-Sinai Medical Office; 🇺🇸 Los Angeles, California, United States

South California Permanente Medical Group; 🇺🇸 Pasadena, California, United States

Sherif Aboseif, MD; 🇺🇸 Oxnard, California, United States

Midwest Institute for Research & Education; 🇺🇸 West Chester, Ohio, United States

McKay Urology; 🇺🇸 Charlotte, North Carolina, United States

North Shore University Health System; 🇺🇸 Evanston, Illinois, United States

St. Lukes Hospital and Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology; 🇺🇸 Philadelphia, Pennsylvania, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center at Dallas - Department of Urology; 🇺🇸 Dallas, Texas, United States

Vanguard Urologic Research Foundation; 🇺🇸 Houston, Texas, United States

Scott & White Memorial Hospital; 🇺🇸 Temple, Texas, United States

Virgina Mason Medical Center - Section of Urology and Renal Transplantation; 🇺🇸 Seattle, Washington, United States

Gary Steinhoff Clinical Research; 🇨🇦 Victoria, British Columbia, Canada

Discovery Clinical Trials; 🇺🇸 Winter Haven, Florida, United States

Genitourinary Surgical Consultants; 🇺🇸 Denver, Colorado, United States

Medical University of South Carolina - Department of Urology; 🇺🇸 Charleston, South Carolina, United States

Ochsner Clinic; 🇺🇸 New Orleans, Louisiana, United States

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

LSU Health Science Center; 🇺🇸 New Orleans, Louisiana, United States