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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Jelly +/- Lidocaine Periurethral Injection for Urethral Bulking Analgesia: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07889687
- Acronym / sponsor ID
- 25-0504
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind RCT
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Gyldo, Drug: SalineGlydo + Saline injection |
| Arm 2 | Experimental | Drug: Lidocaine injection, Drug: GyldoGlydo + Lidocaine injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SUI based on +CST or UDS
Key exclusion criteria (1 listed)
- contraindication to lidocaine, allergy to coaptite, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine injectionPeriurethral injection of lidocaine | Drug | Arm 2 |
| GyldoGlydo | Drug | Arm 1, Arm 2 |
| SalineSaline injection | Drug | Arm 1 |
Primary outcome
Pain score
Time frame: Immediately after procedure
0-100mm visual analog score
3 secondary outcomes
UDI-6
Time frame: 2 weeks after procedure
IIQ-7
Time frame: 2 weeks after procedure
PGI-I
Time frame: 2 weeks after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine injection, Gyldo and Saline in people with Pain, run by Northwell Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly Gridley Co-investigator, MD (815-631-4840, cgridley@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.