46 Participants NeededMy employer runs this trial

Lidocaine Injection vs Saline for Pain Management

Recruiting at 2 trial locations
CG
Overseen ByCarly Gridley Co-investigator, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Northwell Health
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people undergoing a urethral bulking procedure to treat urine leakage during activities like coughing or laughing. Participants must be eligible for this procedure and able to receive either numbing medication or saline injections.

Inclusion Criteria

SUI based on positive CST or UDS

Exclusion Criteria

Contraindication to lidocaine
Allergy to coaptite
Pregnancy

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine injection

Trial Overview

The study compares two ways of managing pain: injecting lidocaine (a numbing medicine) versus injecting saline (saltwater, which has no numbing effect) around the urethra during the bulking procedure. All participants also get standard lidocaine gel inside the urethra.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 2Experimental Treatment2 Interventions
Group II: Arm 1Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+