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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 46 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 3 sites (Bay Shore, New York and 2 other locations) |
| Status | Recruiting |
| Started | October 26, 2025 |
| Main results expected | April 2027 |
| Study ends | July 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07889687 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
- Study coordinator: Carly Gridley Co-investigator, MD
- Email: cgridley@northwell.edu
- Phone: 815-631-4840
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.