跳至主要内容
临床试验/NCT01903590
NCT01903590已完成不适用

PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY

Zekai Tahir Burak Women's Health Research and Education Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6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
100
试验地点
2
主要终点
Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency

研究概览

简要总结

The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.

详细描述

Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a computer generated randomisation code,to the TVT or TOT. The patients will be aware of the type of the surgical procedure before the operation.

Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ) staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12 months postoperatively.Objective cure is defined as a negative cough stress test .Negative cough stress test ,but occasional urine leakage during stress will be considered ''improved''.

Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative<10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative<preoperative).

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with urinary stress incontinence with no intrinsic sphincter deficiency
  • Women with or without pelvic organ prolapse

排除标准

  • Previous incontinence surgery
  • Urge incontinence or overactive bladder
  • Mixed incontinence
  • Intrinsic sphincter deficiency
  • Body mass index>35
  • Un-willing for randomisation

结局指标

主要结局

Comparison of the efficiency of TVT and TOT in stress incontinence with no intrinsic deficiency

时间窗: One year

Postoperative UDI-6 and IIQ-7 \<10 and negative cough test will be defined as ''cured''

次要结局

  • Objective effectiveness by cough test at 6 and 12 th months postoperatively(One year)
  • Subjective effectiveness by UDI-6 and IIQ-7 at 6-12 th months postoperatively(One year)
  • Short term and long term surgical complications(One year)
  • The prevalence of voiding dysfunction at 1 and 12 th months postoperatively(One year)

研究者

发起方
Zekai Tahir Burak Women's Health Research and Education Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabri Cavkaytar

Obstetrics and Gynecology specialist

Zekai Tahir Burak Women's Health Research and Education Hospital

研究点 (2)

Loading locations...

相似试验