Intraurethral Lidocaine After Endourology Procedures
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San Antonio Uniformed Services Health Education Consortium
临床试验: NCT03537534
BioSeek: nct03537534
关键词
抽象
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.
日期
最后验证: | 04/30/2018 |
首次提交: | 05/14/2018 |
提交的预估入学人数: | 05/14/2018 |
首次发布: | 05/24/2018 |
上次提交的更新: | 05/14/2018 |
最近更新发布: | 05/24/2018 |
实际学习开始日期: | 04/14/2018 |
预计主要完成日期: | 01/31/2019 |
预计完成日期: | 04/30/2019 |
状况或疾病
Dysuria
干预/治疗
Drug: Experiment
Drug: Placebo
相
相 3
手臂组
臂 | 干预/治疗 |
---|---|
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 |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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 - |
结果
主要结果指标
1. Subjective patient symptom score [1 day (immediately before and after procedure)]
questionnaire scores
次要成果指标
1. Patient complications [within 30 days]
Unplanned patient returns to clinic or ED, UTIs, admissions