Stress Urinary IncontinenceNCT00629083
Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
A study testing Bulkamid and Contigen in people with Stress Urinary Incontinence, run by Contura at 34 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Bulkamid and Contigen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 34 sitesin 3 countries
- Study dates
- Apr 2008to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States28 sites
Northeast Urogynecology
Albany, New York, 12205
St. Lukes Hospital and Health Network
Allentown, Pennsylvania, 18104
University of Vermont - The Continence Center
Burlington, Vermont, 05403
Medical University of South Carolina - Department of Urology
Charleston, South Carolina, 29425
McKay Urology
Charlotte, North Carolina, 28207
The Urology Group
Cincinnati, Ohio, 45212
Urology Clinics of North Texas
Dallas, Texas, 75231
UT Southwestern Medical Center at Dallas - Department of Urology
Dallas, Texas, 75390
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Incontinence Research Institute
Encinitas, California, 92024
North Shore University Health System
Evanston, Illinois, 60201
Vanguard Urologic Research Foundation
Houston, Texas, 77030
Mayo Clinic - Department of Urology
Jacksonville, Florida, 32224
Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
Los Angeles, California, 90048
University of Miami and Jackson Memorial Hospital
Miami, Florida, 33136
Specialists in Urology
Naples, Florida, 34102
Ochsner Clinic
New Orleans, Louisiana, 70121
LSU Health Science Center
New Orleans, Louisiana, 70122
Sherif Aboseif, MD
Oxnard, California, 93030
South California Permanente Medical Group
Pasadena, California, 91101
Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
Philadelphia, Pennsylvania, 19104
Urology San Antonio
San Antonio, Texas, 78229
Virgina Mason Medical Center - Section of Urology and Renal Transplantation
Seattle, Washington, 98101
Stanford UniveritySchool of Medicine - Departmert of OB/GYN
Stanford, California, 94305
Scott & White Memorial Hospital
Temple, Texas, 76508
Michigan Urology
Troy, Michigan, 48084
Midwest Institute for Research & Education
West Chester, Ohio, 45069
Discovery Clinical Trials
Winter Haven, Florida, 33881
Canada5 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Can-Med Clinical Research, Inc.
Victoria, British Columbia, V8T 5G1
Gary Steinhoff Clinical Research
Victoria, British Columbia, V8V3N1
About this study
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
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
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Bulkamid, Contigen
- Keywords
- SUI, Bulkamid, Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulkamidDevice
Bulking injection with Bulkamid injection device
ContigenDevice
Transurethral bulking injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bulkamid Hydrogel injection Receives: Device: Bulkamid |
| 2 | Active comparator | Contigen injection Receives: Device: Contigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months
Number of Incontinence Episodes
The total number of incontinence episodes experienced by the subject over three consecutive days.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contura
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Responsible party
- Sponsor
- Investigators
- Silvia Garcia-Codony, Study director, Contura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629083
- Sponsor's protocol ID
- CONSUI-US01
- Status last verified
- Dec 2019
- First submitted
- 26 Feb 2008
- Last updated
- 7 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00629083
- Acronym / sponsor ID
- CONSUI-US01
- Conditions
- Stress Urinary Incontinence
- Keywords
- SUI, Bulkamid, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- ConturaIndustry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Study start
- Apr 2008 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 7 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: BulkamidBulkamid Hydrogel injection |
| 2 | Active comparator | Device: ContigenContigen injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulkamidBulking injection with Bulkamid injection device | Device | 1 |
| ContigenTransurethral bulking injection | Device | 2 |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 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
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
Time frame: 12 months
The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.
5 secondary outcomes
24hr Pad Test
Time frame: 12 months
Number of Subjects Reporting as a Responder
Time frame: 12 months
IQoL
Time frame: 12 months
ICIQ-UI Short Form
Time frame: 12 months
Number of Incontinence Episodes
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Garcia-Codony study director
Contura
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulkamid and Contigen in people with Stress Urinary Incontinence, run by Contura at 34 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.