Clinical Efficacy Of Autologous Fascia Lata Mid-urethral Sling Versus Polypropyelene Mesh Outside-in Transobturator Tape In The Management Of Stress Urinary Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- •Urodynamically proven cure of SUI.
研究概览
简要总结
Clinical efficacy of Autologous Facia Lata Mid-Urethral Sling versus Polypropyelene mesh Outside-In Transobturator Tape in the management of Stress Urinary Incontinence.
This comparative study of Outside-in Transobturator Tape and Fascia Lata surgery in SUI will help us understanding which surgical procedure yields better outcome in terms of alleviating SUI symptoms. Investigating the comparative safety profiles will help in identify which procedure has lower rate of complication like mesh-related issues or post-operative pain. This study has not been conducted recently so research finding in this area can influence clinical guidelines and recommendation, shaping standard practices in the treatment of SUI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with Stress Urinary Incontinence requiring surgical management 2.Women who have completed their families 3.Willing to participate.
排除标准
- •1.Previous failed surgeries for incontinence.
- •2.Vaginal prolapse requiring treatment.
- •3.Neurological disease like Parkinson’s disease, multiple sclerosis.
- •4.Bleeding diathesis.
- •5.History of spinal surgery.
结局指标
主要结局
•Urodynamically proven cure of SUI.
时间窗: 0,6weeks,3months
次要结局
- 1.Post-operative complication like post-operative urinary retension,SSI, UTI, any other urinary complaint in both the surgeries.(2.Improvement in the quality of life assessed by the Incontinence Impact Questionnaire)
研究者
Dr Rajesh Kumari
AIIMS, New Delhi