PainPhase 4NCT07889687
This Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens.
A Phase 4 study testing Lidocaine injection, Gyldo and Saline in people with Pain, run by Northwell Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine injection, Gyldo and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2025to Jul 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SUI based on +CST or UDS
Who cannot join
- contraindication to lidocaine, allergy to coaptite, pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwell health physician partners
Bay Shore, New York, 11706
Carly Gridley, MD, 815-631-4840, cgridley@northwell.edu
- Recruiting
Northwell Health Physician Partners
Huntington, New York, 11743
Carly Gridley, MD, 815-631-4840, cgridley@northwell.edu
- Recruiting
Northwell Health Physician Partners
Smithtown, New York, 11787
Carly Gridley, MD, 815-631-4840, cgridley@northwell.edu
About this study
Official title: Lidocaine Jelly +/- Lidocaine Periurethral Injection for Urethral Bulking Analgesia: A Single-Blind Randomized Controlled 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.
- Conditions
- Pain
- Being tested
- Lidocaine injection, Gyldo, Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine injectionDrug
Periurethral injection of lidocaine
GyldoDrug
Glydo
SalineDrug
Saline injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Glydo + Saline injection Receives: Drug: Gyldo; Drug: Saline |
| Arm 2 | Experimental | Glydo + Lidocaine injection Receives: Drug: Lidocaine injection; Drug: Gyldo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
0-100mm visual analog score
Measured: Immediately after procedure
Secondary outcomes (3)
UDI-6
Incontinence scale
Measured: 2 weeks after procedure
IIQ-7
Incontinence scale
Measured: 2 weeks after procedure
PGI-I
overall improvement after procedure
Measured: 2 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start26 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single blind RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889687
- Sponsor's protocol ID
- 25-0504
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No