NCT00827645撤回不适用
Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Urinary symptoms as demonstrated by questionnaires
研究概览
简要总结
The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18-80 years
- •symptomatic uterine fibroids
- •scheduled for UAE
- •Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
- •Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
- •Signed consent form
排除标准
- •Age <18 or >80 years
- •women who are unable to read and write English,
- •pregnancy or planned pregnancy in the next 12 months
- •< 6 months postpartum
- •current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
- •women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
- •history of bladder or pelvic cancer or pelvic radiation therapy
- •prior augmentation cystoplasty
- •urethral diverticulum, current or repaired.
结局指标
主要结局
Urinary symptoms as demonstrated by questionnaires
时间窗: 1 year
次要结局
- Sexual dysfunction as defined by questionnaires(1 year)
研究者
研究点 (1)
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