Intraurethral Lidocaine After Endourology Procedures
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Status
Patrocinadores
San Antonio Uniformed Services Health Education Consortium
ENSAIO CLÍNICO: NCT03537534
BioSeek: nct03537534
Palavras-chave
Resumo
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.
datas
| Última verificação: | 04/30/2018 |
| Enviado pela primeira vez: | 05/14/2018 |
| Inscrição estimada enviada: | 05/14/2018 |
| Postado pela primeira vez: | 05/24/2018 |
| Última atualização enviada: | 05/14/2018 |
| Última atualização postada: | 05/24/2018 |
| Data real de início do estudo: | 04/14/2018 |
| Data Estimada de Conclusão Primária: | 01/31/2019 |
| Data Estimada de Conclusão do Estudo: | 04/30/2019 |
Condição ou doença
Dysuria
Intervenção / tratamento
Drug: Experiment
Drug: Placebo
Fase
Fase 3
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| 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 |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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 - |
Resultado
Medidas de Resultado Primário
1. Subjective patient symptom score [1 day (immediately before and after procedure)]
questionnaire scores
Medidas de Resultado Secundário
1. Patient complications [within 30 days]
Unplanned patient returns to clinic or ED, UTIs, admissions
