A Double blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence - Study investigating CMI autologous muscle-derived cells in women

William Cook Europe, Regulatory Affairs, Clinical0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29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.

•Patient has symptoms af pure urge incontinence as confirmed by basic evaluation af etiology from a patient medical history, including a focused incontinence history.
•Patient has symptoms af 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 for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder 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 available for the follow-up evaluations as required by the protocol.

发起方

William Cook Europe, Regulatory Affairs, Clinical