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RECRUITING
NCT07889687
PHASE4

This Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens.

Sponsor: Northwell Health

View on ClinicalTrials.gov

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

DRUG

Lidocaine injection

Periurethral injection of lidocaine

DRUG

Gyldo

Glydo

DRUG

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