The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- outcome of the surgery
研究概览
简要总结
To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.
详细描述
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
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
- 49 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram
排除标准
- •presence of urge or mixed incontinence .
研究组 & 干预措施
Group A
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
干预措施: TVT-O (Procedure)
Group B
post menopausal female with genuine stress incontinence treated by TVT-O only
干预措施: TVT-O (Procedure)
结局指标
主要结局
outcome of the surgery
时间窗: 3 months after surgery
clinical and urodynamic test improvment of the stress incontinence
outcome of the surgery
时间窗: immediately after surgery
clinical and urodynamic test improvment of the stress incontinence
次要结局
- frequency,(immediatly after surgery)
- denovo urgency(3 months after surgery)
- nocturia ,(immediatly after surgery)
- frequency(3 months after surgery)
- nocturia(3 months after surgery)
- denovo urgency(immediatly after surgery)
研究者
sarah mohamed hassan
lecturer of obstetrics and gynecology
Kasr El Aini Hospital