Intraurethral Lidocaine After Endourology Procedures
Primary Purpose
Dysuria
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Jet Injector
Placebos
Sponsored by
About this trial
This is an interventional health services research trial for Dysuria
Eligibility Criteria
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.
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Exclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation
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Sites / Locations
- BAMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experiment
Placebo
Arm Description
Lidocaine jelly (2%) 5mL x 1 dose only
Surgilube 5mL x 1 dose only
Outcomes
Primary Outcome Measures
Subjective patient symptom score
questionnaire scores
Secondary Outcome Measures
Patient complications
Unplanned patient returns to clinic or ED, UTIs, admissions
Full Information
NCT ID
NCT03537534
First Posted
May 15, 2018
Last Updated
May 15, 2018
Sponsor
San Antonio Uniformed Services Health Education Consortium
1. Study Identification
Unique Protocol Identification Number
NCT03537534
Brief Title
Intraurethral Lidocaine After Endourology Procedures
Official Title
Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Antonio Uniformed Services Health Education Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysuria
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment
Arm Type
Experimental
Arm Description
Lidocaine jelly (2%) 5mL x 1 dose only
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Surgilube 5mL x 1 dose only
Intervention Type
Drug
Intervention Name(s)
Lidocaine Jet Injector
Other Intervention Name(s)
Urojet
Intervention Description
Applying Lidocaine following endourologic procedure
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Surgilube
Intervention Description
Applying surgilube following endourologic procedure
Primary Outcome Measure Information:
Title
Subjective patient symptom score
Description
questionnaire scores
Time Frame
1 day (immediately before and after procedure)
Secondary Outcome Measure Information:
Title
Patient complications
Description
Unplanned patient returns to clinic or ED, UTIs, admissions
Time Frame
within 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher L Allam, DO
Phone
210-916-6604
Email
christopher.l.allam.mil@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia Balzano, MD
Phone
210-916-0716
Email
felicia.l.balzano.mil@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Allam, DO
Organizational Affiliation
San Antonio Uniformed Services Health Education Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
BAMC
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Allam, DO
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intraurethral Lidocaine After Endourology Procedures
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