NCT02710422

Miami Membrane for Potency (MMEP) Trial

Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.

Detailed description

This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm. The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery. Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (\<17 vs. \>=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic Membrane Placement	Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.
BEHAVIORAL	EPIC 26	Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
OTHER	PSA Measurement	Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
BEHAVIORAL	Sexual History Inventory for Men	SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Timeline

• Start date: 2016-05-17
• Primary completion: 2019-01-22
• Completion: 2019-01-22
• First posted: 2016-03-16
• Last updated: 2019-09-11
• Results posted: 2019-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study