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• W4377246161 abstract "Abstract Introduction Peyronie’s Disease (PD) is prevalent in approximately 7.1% of the general population. Current treatment approaches include medical therapy and surgical intervention, and intervention only occurs once the disease process has entered the chronic, stable phase. The only FDA-approved medical therapy involves use of intralesional collagenase clostridium histolyticum injection and surgical interventions include tunica albuginea plication, plaque excision without grafting, or placement of penile prothesis. Autologous platelet rich plasma (PRP) may prove to be a viable treatment for this patient population due to its ability to facilitate tissue repair and wound healing via various growth factors. Objective We hypothesized that PRP can be safely utilized in patients with PD, with minimal adverse events. Methods We reviewed data for an initial series of men recruited into an ongoing randomized double-blind placebo-controlled cross-over study at the University of Miami from April 2021 to June 2022. Patients received a total of two injections of PRP or placebo directly into the dominant plaque, separated by two weeks. Patients were observed immediately post-injection and assessed with Visual Analogue Pain Scale, and at follow-up for complications and tolerability. Patients are followed three- and six-months post-injection, of which then the patient crosses over into the other treatment / placebo arm. The patient undergoes goniometer measurement with an artificial erection, IIEF-15 and PDQ questionnaire assessment prior to crossover and at the end of the study. ClinicalTrials.gov Identifier: NCT04512287. Results We report data from 24 men who completed two injections for Arm 1 (PRP or placebo) and 15 men who completed two injections (PRP or placebo) after cross-over. No post-procedural minor adverse events were seen in any of the men. None of the participants reported adverse effects such as penile bruising, swelling, edema, allergy, penile fracture, or mild pain at injection site. Six men completed 6-month follow-up and no complications were reported. No worsening curvature was observed in men completing pre/post evaluations. Conclusions PRP appears to be a safe and feasible treatment modality in patients with PD from our limited data accumulated thus far in our ongoing randomized placebo-controlled trial with PRP for PD. We expect to report efficacy data as soon as it becomes available. Our study is the first study in the USA accruing men with PRP for PD in a clinical trial and believe that safety and efficacy data accumulated from our study will be important for patient counseling. Disclosure No" @default.
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• W4377246161 date "2023-05-01" @default.
• W4377246161 modified "2023-10-15" @default.
• W4377246161 title "(162) Safety and Feasibility of Platelet-Rich Plasma Injections for Peyronie’s Disease: A Randomized Double-blind Placebo-controlled Cross-over Study" @default.
• W4377246161 doi "https://doi.org/10.1093/jsxmed/qdad060.157" @default.
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