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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bulkamid
Contigen
Sponsored by
Contura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring SUI, Bulkamid, Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Incontinence Research Institute
  • Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
  • Sherif Aboseif, MD
  • South California Permanente Medical Group
  • Stanford UniveritySchool of Medicine - Departmert of OB/GYN
  • Genitourinary Surgical Consultants
  • Mayo Clinic - Department of Urology
  • University of Miami and Jackson Memorial Hospital
  • Specialists in Urology
  • Discovery Clinical Trials
  • North Shore University Health System
  • Ochsner Clinic
  • LSU Health Science Center
  • Michigan Urology
  • Northeast Urogynecology
  • McKay Urology
  • The Urology Group
  • Midwest Institute for Research & Education
  • St. Lukes Hospital and Health Network
  • Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
  • Medical University of South Carolina - Department of Urology
  • Urology Clinics of North Texas
  • UT Southwestern Medical Center at Dallas - Department of Urology
  • Vanguard Urologic Research Foundation
  • Urology San Antonio
  • Scott & White Memorial Hospital
  • University of Vermont - The Continence Center
  • Virgina Mason Medical Center - Section of Urology and Renal Transplantation
  • Can-Med Clinical Research, Inc.
  • Gary Steinhoff Clinical Research
  • Sunnybrook Health Sciences Centre
  • Jewish General Hospital
  • University of Sherbrooke
  • Hopital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Bulkamid Hydrogel injection

Contigen injection

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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).
Number of Incontinence Episodes
The total number of incontinence episodes experienced by the subject over three consecutive days.

Full Information

First Posted
February 26, 2008
Last Updated
January 28, 2020
Sponsor
Contura
Collaborators
Regulatory and Clinical Research Institute (RCRI)
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1. Study Identification

Unique Protocol Identification Number
NCT00629083
Brief Title
Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contura
Collaborators
Regulatory and Clinical Research Institute (RCRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
SUI, Bulkamid, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bulkamid Hydrogel injection
Arm Title
2
Arm Type
Active Comparator
Arm Description
Contigen injection
Intervention Type
Device
Intervention Name(s)
Bulkamid
Intervention Description
Bulking injection with Bulkamid injection device
Intervention Type
Device
Intervention Name(s)
Contigen
Intervention Description
Transurethral bulking injection
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
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
Time Frame
12 Months
Title
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
Description
The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
24hr Pad Test
Description
A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.
Time Frame
12 months
Title
Number of Subjects Reporting as a Responder
Description
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.
Time Frame
12 months
Title
IQoL
Description
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.
Time Frame
12 months
Title
ICIQ-UI Short Form
Description
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).
Time Frame
12 months
Title
Number of Incontinence Episodes
Description
The total number of incontinence episodes experienced by the subject over three consecutive days.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Garcia-Codony
Organizational Affiliation
Contura
Official's Role
Study Director
Facility Information:
Facility Name
Incontinence Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Sherif Aboseif, MD
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
South California Permanente Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Facility Name
Stanford UniveritySchool of Medicine - Departmert of OB/GYN
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Mayo Clinic - Department of Urology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami and Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Discovery Clinical Trials
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
LSU Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Michigan Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Northeast Urogynecology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Midwest Institute for Research & Education
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
St. Lukes Hospital and Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina - Department of Urology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas - Department of Urology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Vanguard Urologic Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Vermont - The Continence Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Virgina Mason Medical Center - Section of Urology and Renal Transplantation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Can-Med Clinical Research, Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Gary Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V3N1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
University of Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

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