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

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

Non Recruiting
40-80 years
Male
Phase 2

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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.

Eligibility

Inclusion 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).

Exclusion Criteria:

  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.

Study details
    Prostate Cancer
    Erectile Dysfunction Following Radical Prostatectomy

NCT05842057

University of Miami

20 August 2025

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