NCT06451796招募中不适用
A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
MagCath1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety primary: Migration of device to bladder
研究概览
简要总结
Hypothesis: Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence.
Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks
详细描述
Demonstrate ease and comfort of device insertion, indwelling and removal. Patient acceptability during use.
Other:
- Symptom and QOL questionnaire.
- Drop out analysis.
- Is the patient motivated to continue using the valve catheter?
- Is the patient motivated to recommend the valve catheter to other stress incontinent women?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to participate
- •Adult, competent woman who understands Danish.
- •SUI as dominant symptom; daily or almost daily.
- •Residual urine < 150 ml.
- •POP-Q prolapse ≤ grade
- •Negative urine stix/Urine D+R.
- •Min. 2 months local vaginal estrogen treatment if the woman is postmenopausal.
- •Mobile and self-reliant woman.
- •Motivated.
排除标准
- •Allergy to the silicone material
- •Pregnancy or breastfeeding
- •Unexplained hematuria.
- •Current inflammatory disorders
- •Malignant disorders of the urethra.
- •Urethral stricture
- •Visual diverticulum.
- •AK treatment.
- •Prosthetic heart valve surgery.
结局指标
主要结局
Safety primary: Migration of device to bladder
时间窗: 2 weeks
Number of Participants with Migration of device to bladder
次要结局
- Safety secondary: Culture confirmed urinary tract infections.(2 weeks)
- Safety secondary: Allergy.(2 weeks)
- Safety secondary: Discomfort at catheter removal.(2 weeks)
- Safety secondary: Loss of device.(2 weeks)
- Safety secondary:Need for antibiotics.(2 weeks)
- Safety secondary: Discomfort at self-catheterization.(2 weeks)
- Safety secondary: Difficulties emptying the bladder.(2 weeks)
- Safety secondary: Hematuria (stick test/macroscopic).(2 weeks)
研究者
研究点 (1)
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