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临床试验/NCT02406638
NCT02406638已完成不适用

Pelvic Floor 3D Ultrasound of Women Who Underwent TVT-R, TVT-O, TVT-S Surgery at Three Years Follow-up

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
1
主要终点
Determination of the tape spatial position ( angle between tape arms surrounding urethra measured in grades) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)

研究概览

简要总结

Compare through 3D USG the tape spatial orientation, in three different techniques of insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results in an average of three years follow-up.

Methods: This is a transversal study of a cohort women surgically treated for stress urinary incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit, from April 2013 to June 2014, .

详细描述

Introduction: The three dimensional ultrasonography (3D USG) provides a clear spatial orientation of polypropylene tape and can help clarify the pathogenesis of bladder dysfunction after a TVT procedure. Thus, the USG in urogynecology postoperative has shown an increasing role in monitoring surgically treated patients and specially in complications such as urinary retention and urinary disorders.

Objective: Compare through 3D USG the tape spatial orientation, in three different techniques of insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results in an average of three years follow-up.

Methods: This is a transversal study of a cohort of women surgically treated for stress urinary incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision sling (TVT-S). The surgeries occurred from May 2009 to December 2011. Were eligible for the study 158 patients. The clinical and USG evaluation were performed at the same medical visit, from April 2013 to June 2014, after local ethics committee approval and signature of informed consent. The objective cure rates were evaluated by negative pad-test and stress test. The subjective cure rate and urgency symptoms were accessed by questionnaires. The subjective cure was defined as absence of reports of stress urinary leakage.

The USG evaluation was performed using General Electric Voluson 730 expert systems with 8 - 4 Mhz volume transducers with an 85-degree acquisition angle. The exams were performed with patient in supine position with hip flexed and using slightly abduced, after voiding. The US transducer was placed on the perineum in the midsagittal position and volumes were obtained at rest, at maximum Valsalva, and perineal contraction. Moved mode rendering for OMNINI View plan as previous described.The volumes datasets were analyzed offline by of the authors. They were blinded and the average values were considered.

The urethral length and the location of the sling, measured by the distance between bladder neck and the tape (CF), were assessed in midsagittal plane. The tape angle in relation to the urethra were assessed in OMINI VIEW plan.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who underwent surgical treatment for stress urinary incontinence using TVT, TVT-O and TVT-Secur, in a period of 2 to 4 years before the USG evaluation
  • Informed consent signed

排除标准

  • Patients who underwent to more than one surgery for urinary incontinence using polypropylene tape
  • Ultrasound images that would not allow adequate visualization of the tape

结局指标

主要结局

Determination of the tape spatial position ( angle between tape arms surrounding urethra measured in grades) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)

时间窗: evaluation will occur in 1 day, 3 years after surgery

Measured of the angle between tape arms surrounding urethra (in grades) in the three different suburethral tapes measured by 3D USG at rest Valsalva and pelvic floor contraction

次要结局

  • Correlation between the suburethral tape spatial positon and objective cure rate(evaluation will occur in 1 day, 3 years after surgery)
  • Determination of the tape position, relation between urethral length and distance between tape and vesical neck (measured in mm) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)(evaluation will occur in 1 day, 3 years after surgery)
  • Determination of the tape position, distance between the tape and vesical neck (measured in mm) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)(evaluation will occur in 1 day, 3 years after surgery)
  • Correlation between the suburethral tape spatial positon and subjective cure rate(evaluation will occur in 1 day, 3 years after surgery)
  • Correlation between the suburethral tape spatial positon and urge-symptoms(evaluation will occur in 1 day, 3 years after surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Maria Homem de Mello Bianchi

PhD

Federal University of São Paulo

研究点 (1)

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