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临床试验/NCT02101489
NCT02101489已完成不适用

Precise Transvaginal Tape Placement Trial

Loyola University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra.

研究概览

简要总结

This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra.

详细描述

This study will assess the effect of intraoperative measurement of the urethral length with the Foley catheter in optimization of sling placement in the mid female urethra. Of note, the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. Women who have chosen to undergo trans-vaginal tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. Randomization will be performed by the FPMRS study nurse coordinator after a woman has given her informed consent and meets the study criteria. Twenty women will be randomized to undergo measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the Foley catheter) for the treatment of symptomatic stress urinary incontinence All women participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration. Of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. All ultrasound measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl, Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient Global Impression of Improvement (PGII) [11, 12].

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
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

入选标准

  • Candidates for TVT
  • >=18 years of age to participate

排除标准

  • Inability to give informed consent
  • Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral bulking agents
  • Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
  • Pregnant women cannot participate

结局指标

主要结局

If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra.

时间窗: 2 weeks

measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made.

次要结局

  • Comparing urethral length measurement with the Foley catheter and 3D ultrasound.(2 weeks)
  • Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery.(2 weeks)
  • Stratify the data based on patient race, BMI, prolapse and age(6 weeks)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Mueller

M.D., Associate Professor

Loyola University

研究点 (2)

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