Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
研究概览
简要总结
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence
排除标准
- •Pregnancy
- •Women with neurogenic bladder dysfunction
- •Recurrent stress urinary incontinence
- •Woman with history of pelvic surgery
- •Mixed urinary incontinence with prevalence urgency urinary incontinence
- •Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2)
- •Women with acute urinary tract infection
- •Women with bladder outlet obstruction
- •Women who are not able to give informed consent or participate with this randomized research study for any other reason
研究组 & 干预措施
midurethral tension free tape
干预措施: surgical management of stress urinary incontinence with midurethral tension free tape. (Procedure)
Midurethral synthetic tape with tension control mechanism
干预措施: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism. (Procedure)
结局指标
主要结局
Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
时间窗: 1 year
The UDI measures the impact of urinary incontinence on activities, roles, and emotional states in women. This questionnaire presented six questions related to urinary disorders. The patient could answer "Not at all", "A little bit", "Moderately" or "Greatly", to each of the questions, each answer is evaluated at 0, 1, 2 or 3 points, respectively, and then summed up. The final score means that the greater the sum of the indicators, the worse the patient's condition. This score reflects the condition of the patient before and after surgery at 12 weeks and 1 year.
次要结局
- Stress cough test measured before and after surgery.(1 year)
- Bladder outlet obstruction measured during urodynamics pressure flow study(1 year)
研究者
Gevorg Kasyan
Professor
Moscow State University of Medicine and Dentistry