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Clinical trial

Miami Membrane for Potency (MMEP) Trial (MMEP)

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Last updated:1st Apr 2016

The use of dehydrated human amnionic membrane allograft will result in an absolute 20% increase (from 40-60%) in the proportion of men considered potent (Sexual History Inventory for Men (SHIM) score >/= 19) 12 months post robotic assisted radical prostatectomy (RARP)

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Miami Membrane for Potency (MMEP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft on Early Return of Erectile Function
Estimated Enrollment: 280
Study Start Date: April 2016
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

- Experimental: Arm 1
- Amniotic Membrane Placement
- Arm 2 - No Amniotic Membrane Placement

Category Value
Study start date 2016-04-01

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