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NCT07889687
This Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens.
Conditions: Pain
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 46
Sponsor: Northwell Health
Location: Northwell health physician partners Bay Shore New York
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.
Eligibility Criteria
Inclusion Criteria:
* SUI based on +CST or UDS
Exclusion Criteria:
* contraindication to lidocaine, allergy to coaptite, pregnancy
Source: ClinicalTrials.gov (NCT07889687). StuddyBuddy aggregates publicly available trial information.