DysuriaPhase 3NCT03537534

Intraurethral Lidocaine After Endourology Procedures

A Phase 3 study testing Lidocaine Jet Injector in people with Dysuria, run by San Antonio Uniformed Services Health Education Consortium at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Dysuria
What is being tested?: Lidocaine Jet Injector
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2018to 1 Sep 2022
Phase: Phase 3
Are there results?: None posted in the registry

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 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Inclusion Criteria: Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.

Exclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation

Trial locations and contacts

1 site in 1 country.

United States1 site

BAMC
Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

Official title: Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients

Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.

Conditions: Dysuria
Being tested: Lidocaine Jet Injector, Placebos
Medical subject headings: Dysuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine Jet InjectorDrug
Also called Urojet
Applying Lidocaine following endourologic procedure
PlacebosDrug
Also called Surgilube
Applying surgilube following endourologic procedure

Study groups in NCT03537534
Study group	Role	What they receive
Experiment	Experimental	Lidocaine jelly (2%) 5mL x 1 dose only Receives: Drug: Lidocaine Jet Injector
Placebo	Placebo comparator	Surgilube 5mL x 1 dose only Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective patient symptom score
questionnaire scores
Measured: 1 day (immediately before and after procedure)

Secondary outcomes (1)

Patient complications
Unplanned patient returns to clinic or ED, UTIs, admissions
Measured: within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20181 Sep 2022

First posted25 May 2018
Study start15 Apr 2018
Primary completion1 Sep 2022
Study completion1 Sep 2022

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysuriaStudies 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 3
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537534
Sponsor's protocol ID: C.2018.055d
Status last verified: Feb 2024
First submitted: 15 May 2018
Last updated: 26 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysuria trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients
ClinicalTrials.gov ID: NCT03537534
Acronym / sponsor ID: C.2018.055d
Conditions: Dysuria
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of enrollment
Enrolment: 35 participants (actual)
Lead sponsor: San Antonio Uniformed Services Health Education ConsortiumUS federal agency
Study start: 15 Apr 2018 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 25 May 2018 (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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experiment	Experimental	Drug: Lidocaine Jet InjectorLidocaine jelly (2%) 5mL x 1 dose only
Placebo	Placebo comparator	Drug: PlacebosSurgilube 5mL x 1 dose only

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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 Jet InjectorAlso: UrojetApplying Lidocaine following endourologic procedure	Drug	Experiment
PlacebosAlso: SurgilubeApplying surgilube following endourologic procedure	Drug	Placebo

Primary outcome

Subjective patient symptom score
Time frame: 1 day (immediately before and after procedure)
questionnaire scores

1 secondary outcome

Patient complications
Time frame: within 30 days

Results and safety

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Individual participant dataSharing planned: No

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Inguinal Hernias
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Benign Prostatic Hyperplasia
Recruiting
Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy
Prostate Hyperplasia
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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. This study is not recruiting at the moment.

Christopher Allam, DO principal investigator

San Antonio Uniformed Services Health Education Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lidocaine Jet Injector in people with Dysuria, run by San Antonio Uniformed Services Health Education Consortium at 1 site 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?

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: stopped early, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective patient symptom score (time frame: 1 day (immediately before and after procedure)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537534.

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 26 Feb 2024.