Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

Description

The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.

Conditions

Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy

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Study Overview

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Study Details

Study overview

The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.

Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)

Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).
  • 1. Men requiring any use of pads for urinary leakage.
  • 2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
  • 3. Men with baseline EPIC26 scores \< 60.
  • 4. Previous treatment for prostate cancer.
  • 5. Previous history of pelvic radiation.
  • 6. Patients with impaired decision-making capacity.

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Sanoj Punnen, MD, MAS, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2028-08-31