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
Location: See location...
Intervention Type: Other, Biological, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
Locations
United States
Florida
University of Miami
Miami
Time Frame
Start Date: 2016-05-17
Completion Date: 2019-01-22
Participants
Target number of participants: 24
Treatments
Experimental: Arm 1 - Amniotic Membrane Placement
Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
Other: Arm 2 - No Amniotic Membrane Placement
Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Vivex Biomedical
Leads: University of Miami