Miami Membrane for Potency (MMEP) Trial
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 2/2/2019 |
| Start Date: | May 17, 2016 |
| End Date: | January 22, 2019 |
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
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.
(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.
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 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.
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 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.
Inclusion Criteria:
- Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve
sparing RARP at the University of Miami
Exclusion Criteria:
- Men with poor urinary control at baseline requiring the use of pads for leakage
- Previous treatment for prostate cancer
- Previous history of pelvic radiation
- Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous
injections, MUSE, penile prosthesis.
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Sanoj Punnen, MD
Phone: 305-243-3246
University of Miami A private research university with more than 15,000 students from around the...
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