Active — Not RecruitingPhase 2

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

United States118 participantsStarted 2023-08-24

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexMALE

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Exclusion criteria

✕. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).
✕. Men with baseline EPIC26 scores \< 50.
✕. Patients with complete, bilateral nerve resection.
✕. Previous treatment for prostate cancer.
✕. Previous history of pelvic radiation.
✕. Patients with impaired decision-making capacity.

What they're measuring

Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score

Timeframe: Baseline, 12 Months Post-RARP

Trial details

NCT IDNCT05842057

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

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