A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence - IND2

Cook MyoSite Incorporated0 个研究点目标入组 267 人开始时间: 2014年9月16日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•Female patient has primary symptoms of SUI, as confirmed by patient medical history 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 222
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
•Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
•Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
•Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
•Patient has more than 2 episode of awakening to void during normal sleeping hours.
•Patient cannot be maintained 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 of 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 available for the follow-up evaluations as required by the protocol.

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