ISRCTN08364639已完成不适用
Performance of the miniaturo™-I system for treatment of overactive bladder
niversity Medical Center Utrecht (UMCU) (The Netherlands)0 个研究点目标入组 30 人开始时间: 2006年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Females more than 18 years
- •2. Failed conservative treatment for more than six months
- •3. Detrusor overactivity on urodynamic study
- •4. Urinary urge incontinence more than five episodes a day
- •5. Urinary frequency more than 10/day and more than 3/night
- •6. Competent sphincter mechanism
- •7. Normal upper tract
- •8. Passing MST-I session
排除标准
- •1. Participation in another study less than three months
- •2. Any active implant
- •3. Incontinence surgery less than three months
- •4. Spinal or genital surgery less than six months
- •5. Post void residual less than 100 ml
- •6. Leak point pressure more than 100 cm Water (H2O)
- •7. Pelvic pain syndrome
- •8. Stress incontinence
- •9. Cystocele/rectocele/enterocele grade three or four
- •10. Neurological disease
- •11. Morbid obesity
- •12. Severe uncontrolled diabetes
- •13. Severe heart disease
- •14. Requiring frequent Magnetic Resonance Imaging (MRI) exams
- •15. Pregnancy or attempt to get pregnant
- •16. Uncontrolled bleeding coagulopathy
研究者
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