Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain 15 minutes after procedure
研究概览
简要总结
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited.
Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus.
Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women referred to elective outpatient cystoscopy.
排除标准
- •Known urethral stricture.
- •Known allergy to lubricant/anesthesia gel.
- •Patients under the age of 18 (minors).
- •Patients with current Urinary Tract Infections.
- •Chronic pelvic pain (e.g Interstitial Cystitis/Bladder Pain Syndrome.
- •Known neurlogical or other chronic pain syndrome requiring chronic analgesia medication.
- •Mentally incapable for consensual agreement of participation.
研究组 & 干预措施
Rigid cystoscopy, water based gel on introitus
Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.
干预措施: Water (Drug)
Rigid cystoscopy, esracain gel based on introitus
Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
干预措施: Lidocaine (Drug)
Flexible cystoscopy, water based gel on introitus
Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure.
干预措施: Water (Drug)
Flexible cystoscopy, Esracain gel based on introitus
Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain 15 minutes after procedure
时间窗: 15 minutes after end of procedure
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain immediately after procedure
时间窗: Immediately after withdrawal of the cystoscope from the urethra
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain before procedure
时间窗: Before cystoscopy
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain during meatus insertion of cystoscope
时间窗: During the procedure, at the moment of cystoscopy insertion through the urethra
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
次要结局
未报告次要终点
研究者
Prof. Kobi Stav
Senior Urologist
Assaf-Harofeh Medical Center