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
Age 40-75 years
Underwent unilateral or bilateral nerve-sparing radical prostatectomy between 1 and 3 years prior to the study
Good erectile function prior to surgery (IIEF-EF score ≥ 22)
Erectile dysfunction at inclusion with an IIEF-EF score < 22 without aids
Known psychiatric, neurological and/or endocrinological disease requiring medication (including hypogonadism with total testosterone <12 nmol/l).
Severe urinary incontinence preventing sexual activity (assessed by a physician at inclusion)
Clinical or biochemical recurrence of prostate cancer
Other surgery or radiation therapy in the pelvic region
Parallel
Autologous Platelet Rich Plasma
Other interventionA volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections
saline solution (placebo)
Other interventionA volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections.
Change in IIEF-EF score from baseline to 1 month after the final treatment session
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using an intention-to-treat analysis.
Change in IIEF-EF score at 1 month after the final treatment session - per-protocol analysis
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using a per-protocol analysis.
Change in IIEF-EF score at 3, 6, and 12 months after the final treatment session
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 3, 6, and 12 months after the final treatment session. Analyses will be performed using both intention-to-treat and per-protocol populations, comparing the PRP and saline groups.
Analyses of participants achieving a clinically significant improvement in IIEF-EF score at 1, 3, 6, and 12 months
Intention-to-treat and per-protocol analyses of the proportion of participants achieving clinically significant improvements in IIEF-EF at 1, 3, 6, and 12 months following the final treatment session with PRP or saline. Clinically significant improvement is defined according to Rosen et al. as an increase of 2 points for mild ED, 5 points for moderate ED, and 7 points for severe ED
Change in IIEF domain scores at 1, 3, 6, and 12 months
Changes in the remaining domains of the International Index of Erectile Function (IIEF): orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. As no minimum clinically important difference has been established for these domains, changes in domain scores will be analysed as continuous variables and compared between the PRP and saline groups.
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