A Double blind, Randomized, Placebo-Controlled Study Evaluating theSafety and Effectiveness of Cook MyoSite Incorporated AMDC in FemalePatients with Stress Urinary Incontinence - UIAD

Cook Myosite, Incorporated0 个研究点目标入组 246 人开始时间: 2013年12月5日最近更新: 2017年5月22日

适应症

试验速览

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•The patient is female and has primary symptoms af SUl, as confirmed by patient medicai h istory and clinical symptoms, including a focused incontinence evaluation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 184
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 62

•Patient has symptoms af pure urge incontinence as confirmed by basic evaluation af etiology from a patient med icai history, including a focused incontinence history.
•Patient has symptoms af mixed urinary incontinence where urge incontinence is the pr edominant factor.
•Patient has had stress u rinary incontinence symptoms less than 6 months prior to signing the informed consent.
•Patient has not previously attempted conservative treatment for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, blad der
•exercises, biofeedback, etc.)
•Patient has more than 2 episode af awakening to void during normal sleeping hours.
•Patient cannot be ma intained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic
•antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course af the study.
•Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
•Patient refuses to provide written informed consent.
•Patient is not at least 18 years of age.
•Patient is not ava ila ble for the follow-up evaluations as required by the protocol.

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