PROSPECTIVE RANDOMIZED STUDY COMPARING TVT AND TOT IN FEMALE STRESS URINARY INCONTINENCE WITH NO INTRINSIC SPHINCTER DEFICIENCY
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
- 否
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
Sabri Cavkaytar
Obstetrics and Gynecology specialist
Zekai Tahir Burak Women's Health Research and Education Hospital
