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

  • Recruiting
  • Supportive care
  • Interventional
  • Randomized
  • Biological & Procedure
  • PHASE2
  • University of Miami
  • 40 - 80 Years

Study Purpose

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.

Intervention

Biological : BioDFence G3 Placental Tissue Membrane

Procedure : Robot-Assisted Radical Prostatectomy

Eligibility Requirements

info icon Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).

info icon Minimum age: 40

info icon Men requiring any use of pads for urinary leakage.

info icon Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)

info icon Men with baseline EPIC26 scores \< 60.

info icon Previous treatment for prostate cancer.

info icon Previous history of pelvic radiation.

info icon Patients with impaired decision-making capacity.

Recruiting status

Recruiting

Estimated enrollment

240

 
Study start date

Aug 24, 2023

Study end date

Aug 31, 2028

Last updated

Mar 23, 2025

Primary purpose

Supportive care

Design

Interventional

Intervention

Biological & Procedure

Study phase

PHASE2

Allocation

Randomized

 

Sponsor:

University of Miami

Collaborator:

Integra LifeSciences Corporation

Investigator:

Sanoj Punnen, MD, MAS

N/A

Publications

N/A


Websites

N/A

NCT05842057

Clinic Location Investigator Distance RECRUITING STATUS Contact