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Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy: a Randomized Controlled Trial

Treatment of Erectile Dysfunction After Radical Prostatectomy With Platelet-Rich Plasma Injections: a Randomized Controlled Trial

Sponsor
Herlev and Gentofte Hospital (Academic or other)
Enrolment
100 planned
Conditions
Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction
Interventions
Autologous Platelet Rich Plasma; saline solution (placebo)
Ages
adults, older adults
Registry
NCT07863388

Full record on ClinicalTrials.gov

From the registry

This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either two PRP injections or two saline (placebo) injections into the penis, administered one month apart in a double-blind fashion. Erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and at 1, 3, 6, and 12 months after the last injection. The primary objective is to determine whether PRP improves the erectile function domain of the IIEF more than saline at one month after the last injection

Primary outcomes

  • Change in IIEF-EF score from baseline to 1 month after the final treatment session

History

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Registered