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NCT05842057
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Conditions: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy
Sex: Male
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 118
Sponsor: University of Miami
Location: University of Miami Miami Florida
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 Criteria:
1\. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).
Exclusion Criteria:
1. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).
2. Men with baseline EPIC26 scores \< 50.
3. Patients with complete, bilateral nerve resection.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.
Source: ClinicalTrials.gov (NCT05842057). StuddyBuddy aggregates publicly available trial information.
