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This Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens.
Sponsor: Northwell Health
Summary
We are doing this study to find the best way to manage pain during a procedure called urethral bulking. This procedure treats urine leakage that happens with coughing, laughing, sneezing, or physical activity. It works by injecting a gel-like substance around the urethra (the tube that urine comes out of) to help it stay closed when it should. We use a numbing gel (called lidocaine jelly) inside the urethra to help with pain during the procedure. In this study, we will also be administering lidocaine (numbing medication) injected around the urethra or a saline placebo (medical grade saltwater) injection, which has no numbing effect. A placebo is something that looks like a real treatment but doesn't have any medical effect. Both the lidocaine and the saline would be injected around the urethra using a small needle, and we'll compare how well they work at reducing pain.
Official title: Lidocaine Jelly +/- Lidocaine Periurethral Injection for Urethral Bulking Analgesia: A Single-Blind Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2025-10-26
Completion Date
2027-07
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Lidocaine injection
Periurethral injection of lidocaine
Gyldo
Glydo
Saline
Saline injection
Locations (3)
Northwell health physician partners
Bay Shore, New York, United States
Northwell Health Physician Partners
Huntington, New York, United States
Northwell Health Physician Partners
Smithtown, New York, United States