Clinical trial Recruiting at 3 sites Phase 4 Interventional Ages 18 and up Women only

Pain relief during urethral bulking: comparing lidocaine versus saline injections

Official title: Lidocaine Jelly +/- Lidocaine Periurethral Injection for Urethral Bulking Analgesia: A Single-Blind Randomized Controlled Trial

Run by Northwell Health · NCT07889687 · Data updated 2026-11-12

We’re testing whether injecting lidocaine around the urethra reduces pain more than a saline placebo during urethral bulking for stress urinary incontinence.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment46 (estimated)
SponsorNorthwell Health
Academic / other
Locations3 sites (Bay Shore, New York and 2 other locations)
StatusRecruiting
StartedOctober 26, 2025
Main results expectedApril 2027
Study endsJuly 2027
Registry record updatedOctober 22, 2026
Trial IDNCT07889687 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with stress urinary incontinence undergoing urethral bulking who have no contraindication to lidocaine, no allergy to the bulking material, and are not pregnant.

Probably not a fit

Patients who do not experience pain differences between lidocaine and saline or who are not eligible due to safety criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 study compares two pain-management approaches used during urethral bulking, a procedure to treat urine leakage with coughing or activity. Participants receive either lidocaine injected around the urethra or a saline placebo, in addition to a lidocaine jelly used inside the urethra, to see which method more effectively reduces pain during the procedure. The study aims to identify a simple, effective way to improve patient comfort while maintaining the procedure’s effectiveness. Safety monitoring will track adverse events related to injections and the bulking material. Enrollment is limited to individuals with stress urinary incontinence who meet the inclusion criteria and do not have listed contraindications.

Why it matters

Potential benefit: If successful, the preferred pain-prevention approach could make urethral bulking more comfortable for patients.

How similar studies have gone: Previous work in similar pain-management comparisons suggests that local anesthetics can reduce procedural pain, but this exact comparison is being tested in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* SUI based on +CST or UDS

Exclusion Criteria:

* contraindication to lidocaine, allergy to coaptite, pregnancy

Where it's running

  • Northwell health physician partners
    Bay Shore, New York, United States
    Recruiting
  • Northwell Health Physician Partners
    Huntington, New York, United States
    Recruiting
  • Northwell Health Physician Partners
    Smithtown, New York, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.