Performance of the miniaturo™-I system for treatment of Urinary Urge Incontinence to improve the number of leaking episodes

American Medical Systems Australia0 个研究点目标入组 30 人开始时间: 2007年7月24日最近更新: 2020年1月13日

适应症

试验速览

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•1.Patient who failed conservative treatments (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) for at least 6 months.2.Overactive detrusor demonstrated on cystometry during the last 6 months or patients who are regarded as sensory urgency3.Urinary Urge Incontinence greater then 5 episodes per day4.Urinary frequency greater than 10 times/day and 3 times/night5.Patients with competent sphincter mechanism6.Patients with normally functioning upper urinary tract 7.Passing miniaturo-I Test System session

•Exclusion criteria1.Previous participation in another study with any investigational drug or device within the past 3 months2.Any active implant (cardiac or other)3.Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months4.Any spinal or genitourinary surgery within the last 6 months5.Previous abdominoperineal resection of the rectum or radical hysterectomy within the last 6 months 6.Anatomical defects that preclude use of the device7.PVR> 100 ml8.VLPP > 100 cmH2O on urodynamic testing9.Primary pelvic pain syndrome10.Obvious clinically demonstrated genuine stress incontinence11.Presence of cystocele, enterocele or rectocele of grade 3 or 4 (if applicable)12.Any neurological disease or disorder13.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 chemotherapy15.Morbid obesity 16.Severe uncontrolled diabetes17.Any severe heart disease18.Patients requiring frequent magnetic resonance imaging (MRI) exams19.Current pregnancy or attempting to get pregnant (female patient)20.Patient with uncontrolled bleeding coagulopathy.

发起方

American Medical Systems Australia