Platelet-Rich Plasma for Erectile Dysfunction After Prostate Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men who had nerve-sparing radical prostatectomy and still have ED 1–3 years later are randomized to receive two intracavernosal injections of autologous PRP or saline placebo, one month apart, in a double-blind setup. The study uses the IIEF erectile function domain to measure changes from baseline at 1, 3, 6, and 12 months after the last injection. Blood is collected to prepare PRP for those assigned to the active arm, with blinding maintained for participants and the administering physician. The trial aims to determine if PRP provides greater improvement in erectile function than placebo.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Urology, Herlev and Gentofte Hospital
  Herlev, Denmark Recruiting

Study contacts

• Principal investigator: Mikkel Fode, MD, PhD — Herlev and Gentofte Hospital
• Study coordinator: Frederikke Bay Toft, MD
• Email: frederikke.bay.toft.01@regionh.dk
• Phone: +4538689927

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.