Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Bulkamid
* Device: Contigen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bulkamid Hydrogel injection | Device: Bulkamid<br>* Bulking injection with Bulkamid injection device<br>|
| Active Comparator: 2<br>Contigen injection | Device: Contigen<br>* Transurethral bulking injection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUI, Bulkamid, Urinary Incontinence