Recruiting
Phase 4

Lidocaine with Saline

Sponsor:

Northwell Health

Code:

NCT07889687

Conditions

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine injection

Gyldo

Saline

Study Details

Brief 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.

Conditions

Pain

Study ID

NCT07889687

Start date

Oct 26, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • SUI based on +CST or UDS

Exclusion Criteria:

  • contraindication to lidocaine, allergy to coaptite, pregnancy

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1

Glydo + Saline injection

experimental: Arm 2

Glydo + Lidocaine injection

Interventions

Lidocaine injection

Periurethral injection of lidocaine

Gyldo

Glydo

Saline

Saline injection

Primary outcome measure

  • Pain score [ Time Frame: Immediately after procedure ]

Central Contacts and Locations

Central contacts

Carly Gridley Co-investigator, MD

815-631-4840cgridley@northwell.edu

Locations

Northwell health physician partners

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Carly Gridley, MD

815-631-4840cgridley@northwell.edu

Northwell Health Physician Partners

Recruiting

Huntington, New York, United States, 11743

Contacts

Carly Gridley, MD

815-631-4840cgridley@northwell.edu

Northwell Health Physician Partners

Recruiting

Smithtown, New York, United States, 11787

Contacts

Carly Gridley, MD

815-631-4840cgridley@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Oct 22, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.