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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2024

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At a glance

  • Drugs Iltamiocel (Primary)
  • Indications Urinary incontinence; Urinary-Stress-Incontinence
  • Focus Registrational; Therapeutic Use
  • Acronyms IND2
  • Sponsors Cook MyoSite

    • Most Recent Events

    • 01 Nov 2024 Primary endpoint (Participants With 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary) has not been met, according to Results published in the Neurourology and Urodynamics.
    • 01 Nov 2024 Results assessing the efficacy and safety of iltamiocel in females with stress urinary incontinence, published in the Neurourology and Urodynamics.
    • 13 Sep 2021 Results (n=75) of women with persistent or recurrent stress urinary incontinence following surgery, presented at the 116th Annual Meeting of the American Urological Association

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