Intraurethral Lidocaine After Endourology Procedures
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Status
Sponsoren
San Antonio Uniformed Services Health Education Consortium
KLINISCHE STUDIE: NCT03537534
BioSeek: nct03537534
Schlüsselwörter
Abstrakt
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.
Termine
| Zuletzt überprüft: | 04/30/2018 |
| Zuerst eingereicht: | 05/14/2018 |
| Geschätzte Einschreibung eingereicht: | 05/14/2018 |
| Zuerst veröffentlicht: | 05/24/2018 |
| Letztes eingereichtes Update: | 05/14/2018 |
| Letztes Update veröffentlicht: | 05/24/2018 |
| Tatsächliches Startdatum der Studie: | 04/14/2018 |
| Geschätztes primäres Abschlussdatum: | 01/31/2019 |
| Voraussichtliches Abschlussdatum der Studie: | 04/30/2019 |
Zustand oder Krankheit
Dysuria
Intervention / Behandlung
Drug: Experiment
Drug: Placebo
Phase
Phase 3
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: Experiment Lidocaine jelly (2%) 5mL x 1 dose only | Drug: Experiment Applying Lidocaine following endourologic procedure |
| Placebo Comparator: Placebo Surgilube 5mL x 1 dose only | Drug: Placebo Applying surgilube following endourologic procedure |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 - |
Ergebnis
Primäre Ergebnismaße
1. Subjective patient symptom score [1 day (immediately before and after procedure)]
questionnaire scores
Sekundäre Ergebnismaße
1. Patient complications [within 30 days]
Unplanned patient returns to clinic or ED, UTIs, admissions
