Miami Membrane for Potency (MMEP) Trial

University of Miami

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Other: PSA Measurement; Behavioral: Sexual History Inventory for Men; Biological: Amniotic Membrane Placement; Behavioral: EPIC 26

Study type: Interventional

Funder types: Other

Identifiers

NCT02710422

20150952

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Arm 1 - Amniotic Membrane Placement

Experimental group

Description:

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.

Treatment:

Behavioral: EPIC 26

Biological: Amniotic Membrane Placement

Behavioral: Sexual History Inventory for Men

Other: PSA Measurement

Arm 2 - No Amniotic Membrane Placement

Other group

Description:

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.

Treatment:

Behavioral: EPIC 26

Behavioral: Sexual History Inventory for Men

Other: PSA Measurement