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Miami Membrane for Potency (MMEP) Trial

NCT02710422 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-09-11

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Vivex Biomedical

    collaborator UNKNOWN

  • University of Miami

    lead OTHER

Principal Investigators

  • Sanoj Punnen, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2019-01-22
Completion
2019-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710422 on ClinicalTrials.gov