NL-OMON30732已完成2 期
Performance of the miniaturo*-I system for treatment of urinary urge incontinence. - miniaturo*-I study for Urinary Urge Incontinence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. At least 18 years old female and full body development
- •2. Signed informed consent
- •3. Normal mental status
- •4. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- •5. Patient who failed conservative treatments (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) for at least 6 months.
- •6. Overactive detrusor demonstrated on cystometry during the last 6 months or patients who are regarded as sensory urgency
- •7. Urinary Urge Incontinence greater then 5 episodes per day
- •8. Urinary frequency greater than 10 times/day and 3 times/night
- •9. Patients with competent sphincter mechanism
- •10. Patients with normally functioning upper urinary tract
- •11. Passing MTS-I session
排除标准
- •1. Previous participation in another study with any investigational drug or device within the past 3 months
- •2. Any active implant (cardiac or other)
- •3. Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months
- •4. Any spinal or genitourinary surgery within the last 6 months
- •5. Previous abdominoperineal resection of the rectum or radical hysterectomy within the last 6 months
- •6. Anatomical defects that preclude use of the device
- •7. PVR> 100 ml
- •8. VLPP > 100 cmH2O on urodynamic testing
- •9. Primary pelvic pain syndrome
- •10. Obvious clinically demonstrated genuine stress incontinence
- •11. Presence of cystocele, enterocele or rectocele of grade 3 or 4 (if applicable)
- •12. Any neurological disease or disorder
- •13. Current urinary tract infection or chronic inflammation, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, urethritis, vesicourethral reflux, etc.)
- •14. Pelvic radiotherapy and chemotherapy
- •15. Morbid obesity
- •16. Severe uncontrolled diabetes
- •17. Any severe heart disease
- •18. Patients requiring frequent magnetic resonance imaging (MRI) exams
- •19. Current pregnancy or attempting to get pregnant (female patient)
- •20. Patient with uncontrolled bleeding coagulopathy.
研究者
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