Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post Procedure Discomfort
研究概览
简要总结
The objective of this study is to perform a randomized study, comparing the outcomes of the above two types of cystoscopy in terms of discomfort experienced by the patient, while undergoing the procedure.
详细描述
Cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic tool in urology.Compared with flexible endoscopes, rigid instruments offer better image quality, a wider lumen of the working channel, improved irrigant flow and superior handiness. However, flexible cystoscopes provide more options for patient positioning, enable smooth passage over an elevated bladder neck or median lobe, facilitate full inspection of the bladder because of their movable tip and, what is most important is it significantly improve patient comfort(patient can be positioned in any comfortable position).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with lower urinary tract symptoms
排除标准
- •patients with Suprapubic catheter
- •History of radical prostatectomy or cystoprostatectomy
- •Clinical evidence of urethral stricture, prostatitis
- •Patients with bacterial growth on urine culture
研究组 & 干预措施
Flexible Cystoscopy
Diagnostic flexible cystoscopy for the patients in this arm
干预措施: Diagnostic Flexible Cystosocpy (Diagnostic Test)
Rigid Cystoscopy
Diagnostic rigid cystoscopy is done for the patients in this arm
干预措施: Diagnostic Rigid Cystoscopy (Diagnostic Test)
结局指标
主要结局
Post Procedure Discomfort
时间窗: periprocedure
Discomfort experienced immediately post procedure by the patient defined as a Visual Analogue Scale score of more than 3 (range is from 1 to 10)
Duration of Procedure
时间窗: periprocedure
time taken to complete the entire test in minutes starting from insertion of the cystoscope through the urethral meatus, visualising the entire bladder and urethra , till the removal of the scope after making the observations.
次要结局
未报告次要终点
研究者
Dr. Gaurish Sawant
resident doctor
Maulana Azad Medical College