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临床试验/NCT00945594
NCT00945594已完成不适用

Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.

研究概览

简要总结

The primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.

详细描述

This will be a prospective randomized trial study in order to determine to compare rigid and flexible cystoscopy in female patients. Patients will be recruited from OU Physicians Pelvic and Bladder Health clinic. Patients receive an information leaflet describing the procedure prior to their appointment. All procedures are performed by the attending physician. Procedures performed by residents and/or fellows are excluded from this study. The vulva is cleaned with antiseptic solution and 10 ml of Xylocaine 2% is be instilled into the urethra before the endoscope was introduced. A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA) is used to enable optimal visualization of the lateral bladder wall in those with previous continence surgeries. The investigator may choose to use a 30° scope when appropriate. Cystoscopy is commenced by recording a postvoid residual ensuring appropriate bladder emptying prior to filling. Filling is performed with continuous saline infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). A standard systematic approach was adopted to ensure global assessment of the vesical surface. This included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral orifices. The urethroscopy portion of the procedure is performed last. When performing rigid cystoscopy, a 0° degree lens is used for this portion of the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with the following indications for outpatient cystourethroscopy:
  • Microscopic hematuria or
  • Voiding dysfunction, or recurrence of urinary incontinence, or
  • History of recurrent bacterial cystitis
  • Patient willingness to enroll
  • Patient able to read and understand an English language self- administered questionnaire.

排除标准

  • Severe detrussor overactivity
  • Interstitial cystitis or chronic urethral or bladder pain
  • Acute urinary tract infection
  • Urinary retention defined as a post void residual >120cc
  • Pregnancy or planning pregnancy within the next 3 months
  • Prior urethral surgery
  • Dementia or inability to complete questionnaires

研究组 & 干预措施

Flexible cystoscopy

Experimental

16F flexible cysto urethroscope (Storz, Culver city, CA)

干预措施: Cystoscopy (Device)

Rigid cystoscopy

Experimental

17F, 70° scope (Storz, Culver city, CA)

干预措施: Cystoscopy (Device)

结局指标

主要结局

Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.

时间窗: 1 week after procedure

Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a "yes" or "no"

Duration of Post-procedure Complications

时间窗: 1 week after procedure

Duration of post-procedure complications, surveyed 1 week post procedure

次要结局

  • Visual Analog Pain Scale(Immediately after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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