A Phase 4 interventional study of Lidocaine injection and Gyldo in Pain, sponsored by Northwell Health. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Northwell Health · Phase 4, Interventional, and Prevention
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 46 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.
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Exclusion Criteria:
Glydo + Saline injection
Drug: Gyldo · Drug: Saline
Glydo + Lidocaine injection
Drug: Lidocaine injection · Drug: Gyldo
Periurethral injection of lidocaine
Glydo
Saline injection
Pain score
0-100mm visual analog score
Time frame: Immediately after procedure
UDI-6
Incontinence scale
Time frame: 2 weeks after procedure
IIQ-7
Incontinence scale
Time frame: 2 weeks after procedure
PGI-I
overall improvement after procedure
Time frame: 2 weeks after procedure
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lidocaine