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

Last updated: August 25, 2024
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

2

Condition

Erectile Dysfunction

Prostate Cancer

Male Hormonal Deficiencies/abnormalities

Treatment

BioDFence G3 Placental Tissue Membrane

Robot-Assisted Radical Prostatectomy

Clinical Study ID

NCT05842057
20220852
  • Ages 40-80
  • Male

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: BioDFence G3 Placental Tissue Membrane
Phase: 2
Study Start date:
August 24, 2023
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.