TerminatedPhase 2

Miami Membrane for Potency (MMEP) Trial

Stopped: Lack of Accrual and Inadequate Funding

United States24 participantsStarted 2016-05-17

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group

Timeframe: Baseline, 12 Months Post-RARP

Trial details

NCT IDNCT02710422

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-22

Results submitted2019-07-27

View on ClinicalTrials.gov More Prostate Cancer trials