Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629083
• Other study ID #: CONSUI-US01
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: December 2019
• Source: Contura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Bulkamid
Bulking injection with Bulkamid injection device
• Contigen
Transurethral bulking injection

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	University of Sherbrooke	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Can-Med Clinical Research, Inc.	Victoria	British Columbia
Canada	Gary Steinhoff Clinical Research	Victoria	British Columbia
France	Hopital Tenon	Paris
United States	Northeast Urogynecology	Albany	New York
United States	St. Lukes Hospital and Health Network	Allentown	Pennsylvania
United States	University of Vermont - The Continence Center	Burlington	Vermont
United States	Medical University of South Carolina - Department of Urology	Charleston	South Carolina
United States	McKay Urology	Charlotte	North Carolina
United States	The Urology Group	Cincinnati	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas - Department of Urology	Dallas	Texas
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Incontinence Research Institute	Encinitas	California
United States	North Shore University Health System	Evanston	Illinois
United States	Vanguard Urologic Research Foundation	Houston	Texas
United States	Mayo Clinic - Department of Urology	Jacksonville	Florida
United States	Tower Urology - Institute for Continence - Cedars-Sinai Medical Office	Los Angeles	California
United States	University of Miami and Jackson Memorial Hospital	Miami	Florida
United States	Specialists in Urology	Naples	Florida
United States	LSU Health Science Center	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Sherif Aboseif, MD	Oxnard	California
United States	South California Permanente Medical Group	Pasadena	California
United States	Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology	Philadelphia	Pennsylvania
United States	Urology San Antonio	San Antonio	Texas
United States	Virgina Mason Medical Center - Section of Urology and Renal Transplantation	Seattle	Washington
United States	Stanford UniveritySchool of Medicine - Departmert of OB/GYN	Stanford	California
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Michigan Urology	Troy	Michigan
United States	Midwest Institute for Research & Education	West Chester	Ohio
United States	Discovery Clinical Trials	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Contura	Regulatory and Clinical Research Institute (RCRI)

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Incontinence Episodes	The total number of incontinence episodes experienced by the subject over three consecutive days.	12 months