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

Launched by UNIVERSITY OF MIAMI · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of tissue, called dehydrated human amnion chorion membrane (dHACM), can help men recover their ability to have erections and control urination more quickly after surgery to remove the prostate (a procedure known as radical prostatectomy). The researchers want to see if placing this membrane over the nerves during the surgery can improve recovery times for men diagnosed with localized prostate cancer.

To participate in this study, men need to be between 40 and 80 years old and are scheduled for a specific type of prostate surgery that aims to spare the nerves. However, men who have serious urinary leakage issues, currently use other treatments for erectile dysfunction, or have had prior cancer treatment in the pelvic area are not eligible. If you join the trial, you’ll be closely monitored to see how well your erectile function and urinary control improve after the surgery. This study is currently looking for participants at the University of Miami, and it aims to find better ways to help men regain their quality of life after prostate cancer treatment.

Gender

MALE

Eligibility criteria

• 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.