Treatment of Peyronie's Disease With Platelet-Rich Plasma

In the placebo sessions, the Platelet-Rich Plasma (PRP) sample (prepared using the Magellan Autologous Platelet Separator) will be sent for analysis of platelet concentration levels to ensure the quality of the PRP.

After each injection, both the administering physician and the participant will be asked to state whether they believe the injection contained PRP or saline. They will also be asked to justify their response, which will allow for adjustments to the practical implementation of the blinding process in the Randomized Controlled Trial (RCT), if necessary.

Recording of adverse events following injections to ensure safety. In other studies and clinical practice, no serious adverse events have been reported. However, mild adverse events may include slight pain, ecchymosis, and hematoma.

Dominant curvature angles will be measured using a goniometer based on images of the participants' erect penis (in two planes) at baseline and at follow-up three months after the final injection. The images will be captured in the outpatient clinic following the administration of Alprostadil to ensure high quality and consistency.

Plaque size will be measured at baseline and three months after the final injection using a ruler, calculated as the product of plaque length and width. Participants with more than two plaques or with significant plaque heterogeneity will not have plaque size measured and will be excluded from these analyses but may still participate in the study.

The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported survey that measures the impact and severity of Peyronie's disease (PD) symptoms in 3 domains, including psychological and physical symptoms, penile pain and symptom bother.

Higher domain scores indicate a greater negative impact. The range of scores for each domain is 0 to 24 for PD psychological and physical symptoms, 0 to 30 for penile pain and 0 to 16 for PD symptom bother.

The participants will complete the survey at baseline and three months after the final injection.

The participants will rate the hardness of their erection via the single-item Likert scale EHS, at baseline and three months after the final injection. The scale is from 0-4. 0 is no erection, the higher the score the better erection.

The Major Depression Inventory (MDI) is a patient-reported outcome measure to assist with diagnosing and evaluation of the severity of a patient's depression.

The MDI score ranges from 0 to 50, where 0 represents no depression symptoms and 50 represents the most severe depression symptoms.

The participants will complete the MDI questionnaire at baseline and three months after the final injection.

The MDI is included due to previously described associations between Peyronie's disease and depression. The data may be used to assess the impact of disease progression on potential depressive symptoms.

The participants will be assessed at baseline and three months after the final injection regarding their ability to engage in sexual intercourse. This will be assessed by asking participants a single binary question: whether they are able to engage in sexual intercourse (yes or no).

The participants will be inquired about their preference for surgical intervention in relation to the current penile curvature at baseline and 3 months after the final injection. This will be assessed by asking participants a single binary question: whether they wish to undergo surgery given their current curvature (yes or no).

The participants will complete a Global Assessment Scale Questionnaire regarding overall treatment satisfaction at the 3-month follow-up after the final injection.

The questionnaire consists of a single question regarding the participants' overall satisfaction with the treatment, to be answered on a scale from 1 to 5. A higher value indicates greater satisfaction.