BASIS: Transurethral Bulking Agent Injection versus Single- Incision Sling for Stress Urinary Incontinence
What is Stress Urinary Incontinence?
Stress Urinary Incontinence (SUI) is the involuntary leakage of urine on effort or exertion. Patients with this type of incontinence may leak urine during physical activities such sneezing, coughing, lifting something heavy, or laughing. It is a common condition that can have a negative effect on a patient’s quality of life.
What are we studying?
The purpose of this study is to compare two treatments for people with SUI. Current evidence suggests that they may be less invasive with fewer side effects than full-length mid-urethral sling procedures. These treatments are commercially available, and FDA approved for patients with SUI. Both procedures are routine for your condition and are not experimental.
Transurethral Bulking Agent Injection (TBA): Injection of Bulkamid material into the urethra to lessen SUI by sealing the urethra tighter.
Single-Incision Sling (SIS): Mesh sling placed through a small incision in the vagina which lessens SUI by supporting the urethra during physical straining.
How many people will participate in this study?
About 358 people will be asked to participate in the “BASIS” Study at 6 university health systems nationwide. About 60 people will be asked to participate at Women and Infants. Women and Infants is part of the Pelvic Floor Disorders Network (PFDN), a team of doctors and researchers from clinical research centers around the country.
Participating sites:
University of California San Diego
Kaiser Permanente Southern Region
Duke University
University of Chicago
University of Pennsylvania
University of Texas Southwestern
Women & Infants Hospital of Rhode Island
Will I be compensated?
If you are eligible and choose to participate in the study, you may be paid up to a total of $425 for completing all study visits and questionnaires during the 3-year study period. All clinic visits for both Transurethral Bulking Agent (TBA) and Single-incision Sling (SIS) are the same as regular clinic care and will be billed to you/or your health insurance.
You may be eligible to participate if you:
Are 21 years of age or older, and have bothersome stress urinary incontinence
Do not plan to become pregnant during the study (36- month duration), and
Have not had prior procedures to treat urinary incontinence.
Contact information:
If you are interested in learning more about this study and to find out if you are able to participate, please contact a member of the research team: Leah McKay, Senior Research Assistant: (401) 430-8207 Jennifer Garcia-Israel, Research Assistant: (401) 430-8227 (habla Español) Ann Escher, Research Supervisor: (401) 430-8228
Contact Form
To learn more about the study or to enroll, please contact our research team by filling out the form below.
