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临床试验/NCT05152199
NCT05152199终止不适用

The Assessment of Pain Outcomes During Rigid Cystoscopy in Females With and Without the Use of the Rigid Cystoscope Obturator: A Randomized Control Trial

Todd Moyerbrailean DO FACOG2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
68
试验地点
2
主要终点
Post-Procedure Dysuria

研究概览

简要总结

Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator. Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.

详细描述

Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator (or obturator for short). There are two acceptable insertion techniques for performing cystoscopy in women. Surgeons can perform cystoscope without the use of the obturator by using a "visual" technique where a telescope with a sheath is inserted for entry into the bladder (referred to as cystoscopy without the obturator). Surgeons can also perform cystoscopy by using an obturator with a sheath allowing for smooth entry without needing the telescope (referred to as cystoscopy with the obturator). Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients scheduled for gynecological procedures where cystoscopy is indicated
  • Ability to comprehend and participate in the study

排除标准

  • < 18 years
  • Pregnancy
  • Current pelvic mesh erosion
  • Exposure or pain complications from mesh
  • Genitourinary malignancy;
  • History of recurrent urinary tract infection (e.g., 2 in 6 months)

结局指标

主要结局

Post-Procedure Dysuria

时间窗: Post intervention pain scale assessment within 10 minutes following first void after the procedure.

The participant will be asked to void within 10 minutes of the completed procedure. The participant will then complete a Visual Analog Numeric Pain Scale, where 1 = no pain and 10 = worst possible pain, within 10 minutes of voiding.

次要结局

  • Incomplete Emptying(Within 10 minutes following the first post-procedure void.)
  • Hesitancy(Within 10 minutes following the first post-procedure void.)
  • Straining(Within 10 minutes following the first post-procedure void.)
  • Post-procedure pain(Within 10 minutes following completion of the procedure)
  • Strength of stream(Within 10 minutes following the first post-procedure void.)
  • Bladder pain(Within 10 minutes following the first post-procedure void.)

研究者

发起方
Todd Moyerbrailean DO FACOG
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Todd Moyerbrailean DO FACOG

Associate Professor

Michigan State University

研究点 (2)

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