Hybrid Transobturator Tape Versus Conventional Synthetic Tape: A Randomized Controlled Trial Assessing Safety, Efficacy, and Female Sexual Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain).
研究概览
简要总结
This randomized controlled trial compares the safety, efficacy, and impact on female sexual function of a novel hybrid transobturator tape (combining an autologous rectus fascia strip with a polypropylene mesh) versus standard synthetic transobturator tape in women undergoing surgery for stress urinary 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients suffering from genuine stress urinary incontinence.
- •Failed conservative management (pelvic floor exercises, medical therapy)
- •Written informed consent.
排除标准
- •Mixed urinary incontinence with predominant urge component.
- •High-grade pelvic organ prolapse (POP-Q Stage >= II), which required surgical intervention.
- •Neurogenic bladder or voiding dysfunction (Post-void residual > 100 ml).
- •Coagulopathy or active urinary tract infection.
- •Patients who underwent recent pelvic radiotherapy.
- •Previous incontinence surgery (recurrent cases).
研究组 & 干预措施
Group A (Standard Synthetic TOT)
Patients undergo the standard outside-in transobturator tape procedure using a full synthetic polypropylene tape.
干预措施: Standard Synthetic Transobturator Tape (TOT) (Procedure)
Group B (Hybrid Sling)
Patients undergo the hybrid sling procedure using a composite graft consisting of an autologous rectus fascia strip centrally sutured to polypropylene tape arms.
干预措施: Hybrid Transobturator Tape Sling (Procedure)
结局指标
主要结局
Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain).
时间窗: Assessed at 6 months postoperatively.
Evaluation of local tissue complications and adverse events associated with the sling material.
次要结局
- Objective cure rate(Assessed at 6 months postoperatively.)
- Subjective cure rate and patient satisfaction.(Assessed at 6 months postoperatively.)
- Impact on quality of life and female sexual function.(Assessed at 6 months postoperatively)
- Female sexual function measured by the Female Sexual Function Index (FSFI)(Assessed at 6 months postoperatively)
- Total Operative Time(Intraoperative (from initial skin incision to final wound closure).)
- Length of Postoperative Hospital Stay(Postoperative Day 1 through hospital discharge (up to 7 days).)
研究者
Mahmoud Atef Abd El Aziz
Lecturer of Urology
Benha University