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Clinical Trials in Denmark / NCT07863388
Starting soon Not applicable

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

NCT07863388 · tracked via the Priya Life Science Denmark tracker
Sponsor
Herlev and Gentofte Hospital
Phase
Not applicable
Started
2026-10
Last updated
2026-10-07

Condition(s) studied

Erectile Dysfunction Following Radical ProstatectomyErectile Dysfunction

Investigational drug(s) / intervention(s)

Autologous Platelet Rich Plasmasaline solution (placebo)

Autologous Platelet Rich Plasma: A volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections

saline solution (placebo): A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections.

Study summary

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

Eligibility

Sex
MALE
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Acceptance of a pause in other treatments for erectile dysfunction from 4 weeks before baseline (wash-out) until the 1-month follow-up after the last injection * In a stable relationship lasting at least 6 months with a desire for sexual activity * Able to understand and accept the study protocol Exclusion Criteria: * 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 * Severe cardiac disease in the form of unstable angina, NYHA class \>II heart failure, uncontrolled arrhythmia, or severe symptomatic and/or significant valvular disease * Use of anti-androgen medication * Peyronie's disease and/or previous episodes of priapism * Excessive alcohol consumption (more than 21 units per week)

Primary outcome measure(s)

  • Change in IIEF-EF score from baseline to 1 month after the final treatment session — From baseline to 1 month post the last intervention
    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.

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Herlev and Gentofte Hospital Herlev Denmark

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Other trials for the same condition

Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy Recruiting
Echocardiography in Men With Erectile Dysfunction Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07863388 on ClinicalTrials.gov ↗ ← All trials in Denmark