Abstract Introduction Non-surgical therapies for Peyronie's disease (PD) remain limited and provide only modest benefit. Platelet-rich plasma (PRP), an autologous concentrate of growth factors, has shown promising results in small uncontrolled studies, but supporting evidence is weak. Objective This pilot study examined the feasibility of a randomized controlled trial (RCT) of PRP versus saline, and secondarily evaluated preliminary efficacy outcomes. Methods We planned to enroll 10 men with stable PD and penile curvature of 30–95° in a prospective, double-blind, randomized pilot study. Participants received six weekly intralesional injections (3 PRP, 3 saline) in random order. PRP was prepared immediately before each session by centrifugation of autologous blood; injection syringes were prepared by an unblinded staff member, covered in a plastic sheet, and administered by a blinded investigator. Platelet counts were quantified in aliquots from preparations allocated as saline controls. Primary outcomes were inclusion feasibility, platelet yield and adequacy of blinding assessed by physician and patient guesses. Adverse events and preliminary efficacy were also evaluated by changes in penile curvature, ability to perform intercourse, surgical preference, Peyronie’s Disease Questionnaire (PDQ) score and Erection Hardness Score (EHS) score. Results Of 23 men screened, 10 were included; 11 were ineligible, one declined, and one did not respond. Injection volume started at 10 mL and was reduced to enhance platelet concentration within pain-tolerance limits. Mean injected volume over the study period was 6.5 mL. Platelet counts averaged 601 ×109/L (range 263–789) before and 928 × 109/L (range 683–1290) after adjustment. Correct treatment identification occurred in 38/60 physician guesses (63.3%; 95% CI 50.7–74.4) and 14/60 patient guesses (23.3%; 95% CI 14.4–35.4), with no significant difference between PRP and saline (physicians p = 0.79; patients p = 1.00). Physician accuracy did not improve over time (first 20: 14/20, 70%; last 20: 13/20, 65%; p = 1.00), while patients showed a nonsignificant trend toward improved guessing (first 20: 2/20, 10%; last 20: 8/20, 40%; p = 0.065). No major adverse events occurred. Minor reactions after PRP included transient bruising (23%), localized edema (37%), and pain (7%). All participants completed treatment. Median dominant penile curvature decreased from 50° (range 37–77) to 46.6°(range 27–72), corresponding to a median reduction of 3.5° (range -30-0; p=0.022). Median total PDQ score was 9 (range 2–25) at baseline and 7.5 (1–27) at follow-up, with a median change of 0 (range -20–6, p=0.54). Median EHS was 4 before and after treatment. Six participants wished surgery before treatment; only three did so after. All three participants unable to perform penetrative intercourse at baseline regained this ability at follow-up. Conclusions Inclusion and retention were acceptable, and blinding was effective, especially on the patient level. Only minor adverse events occurred, while platelet counts reached satisfactory levels after volume adjustment. Exploratory analyses indicated a possible therapeutic effect, though interpretation is limited by the pilot design. Overall, the findings confirm feasibility and safety and reinforce the rationale for a RCT. Disclosure No
Heering et al. (Mon,) studied this question.
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