A Prospective single Arm Pilot Study evaluating the Safety and Feasibility of Intralesional Platelet-Rich Plasma Therapy in Patients with Stable Peyronie’s Disease

Protocol Summary

Title A Prospective Single Arm Pilot Study Evaluating the Safety and Feasibility of Intralesional Platelet-Rich Plasma Therapy in Stable Peyronie’s Disease.

Background Peyronie’s Disease is a fibrotic disorder of the tunica albuginea of the penis, resulting in penile curvature, pain, and sexual dysfunction. While intralesional therapies such as verapamil and collagenase Clostridium histolyticum are approved treatments, their high cost and limited availability especially in resource-constrained settings pose significant barriers. Platelet-Rich Plasma, an autologous blood product enriched with growth factors like PDGF, TGF-beta1, VEGF, EGF, has demonstrated antifibrotic and regenerative effects in musculoskeletal and urological applications, including early studies in PD.

Primary Objective To assess the safety and feasibility of administering intralesional PRP in patients with stable PD.

Secondary Objectives To explore preliminary efficacy in terms of penile curvature, plaque size, erectile function IIEF5, and pain during erection VAS.

Study Design This is a prospective, single-arm, open-label pilot study involving 10 male patients aged 18 to 65 years with stable phase PD disease duration  more than 6 months and stable curvature for at least 3 months. Eligible patients will have curvature between 30 degree and 60 degree and an IIEF5 score more than 12.

Methodology Each participant will undergo a baseline evaluation including physical examination, penile curvature measurement, plaque size via ultrasound, IIEF5 scoring, and pain assessment using a Visual Analog Scale VAS. A baseline platelet count will be performed to ensure suitability for PRP therapy minimum platelet count more or equal 100,000 per micro L.

PRP will be prepared from 20 to 30 mL of the patient’s venous blood using a double-spin centrifugation method. Under local anesthesia, intralesional injections will be administered directly into the plaque once weekly for four weeks Week 0, 1, 2, and 3.

FollowUp and Outcomes Participants will be followed at baseline, during each weekly injection, and again at 1 month and 3 months post-treatment.

Primary Outcome Incidence of adverse events and injection tolerability.

Secondary Outcomes Changes in penile curvature by goniometer, plaque size by ultrasound, erectile function by IIEF5, and pain by VAS score.

Data Analysis Descriptive statistics will be used for feasibility and safety analysis. Pre and post treatment outcome comparisons will use paired t tests or Wilcoxon signed rank tests based on data distribution.

Ethical Considerations The study has been approved by the Institutional research cell. Written informed consent will be obtained from all participants. The study adheres to the Declaration of Helsinki and Good Clinical Practice guidelines. Given PRP is autologous, the intervention carries minimal risk, and the potential benefits may include reduced curvature, pain, and improved sexual function.