Evaluation of intralesional injection of platelet derived growth factors PDGF ma in patients with Peyronie's disease

Evaluation of intralesional injection of platelet derived growth factors PDGF ma in patients with Peyronie's disease | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Evaluation of intralesional injection of platelet derived growth factors PDGF ma in patients with Peyronie's disease Islam Fathy Soliman Abdelrahman, Amr Abdel Raheem, Mahmoud Elbitar, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6498718/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Platelets which are the storage pool of growth factors, when they interact with exposed endothelium within wounds or the damaged tissue, these factors are released and work together in harmony with tissue-repair mechanisms such as chemotaxis, angiogenesis cell proliferation, extracellular matrix deposition, and remodeling to promote appropriate wound healing. Aim: To evaluate the effect of the effect of intralesional lyophilized Platelet Derived Growth Factors (PDGF) in patients with Peyronie's disease (PD). Patients and methods: This study was carried out on 42 patients that were recruited in the period from June 2022 till October 2023 with four patients lost at follow-up. An informed consent was taken, and the followings were done history taking, physical examination, Sexual health inventory for men (SHIM), Erection Hardness Score (EHS), Peyronie's Disease Questionnaire (PDQ), intracorporeal injection and penile duplex. All Patients received intra-lesional injections with 6 vials of LGF (lyophilized growth factor), one vial every two weeks for 12 weeks. Outcome: Assessment and follow up of plaque size and penile curvature through a Penile duplex with a 1cc PGE1 (20 micrograms) solution was performed 6 & 12 weeks after the first intra-lesional injection with LGF. Results: The study showed a significant decrease in the angle of curvature by 23.22° with a mean curvature angle 34.62° ± 16.37° before treatment, and 11.40° ± 8.84° after end of injections. It also showed statistically significant improvement in plaque size with average plaque size before treatment 2.70 ± 0.87 cm, which significantly decreased to 1.43 ± 0.44 cm. In addition, PDQ questionnaire showed a respective improvement of 9.18 points for domain 1, 14.74 for domain 2 and 8.3 for domain 3. Regarding EHS before injection there was two patients with E1 response, six patients with E2 response, while After injection there was no E1or E2 response. Clinical implications: Injection of LGF can result in improvement of early cases of Peyronie's disease. Strengths & Limitations: It is the first study objectively the effect of LGF as a line of treatment of early cases of Peyronie's disease. Additional studies are mandated to assess its efficacy in a shame-controlled manner. Conclusions: Findings of intralesional usage of lyophilized Platelet Derived Growth Factors preliminary in cases with Peyronie’s disease suggest a potential role for the treatment. Lyophilized Platelet Derived Growth Factors (PDGF) Peyronie’s disease Plaque Penile curvature Figures Figure 1 Figure 2 Introduction Peyronie’s disease, historically referred to as induratio penis plastica, arises from collagen buildup in the tunica albuginea surrounding the penile corpus cavernosum, forming plaques that can lead to penile shortening and curvature (1). Early-stage management focuses on conservative therapies, including various oral medications (such as vitamin E, para-aminobenzoate, tamoxifen, colchicine, carnitine esters, pentoxifylline), intralesional injection treatments (steroids, verapamil, collagenase, interferon), and topical or device-based options (verapamil, iontophoresis, shock wave therapy, traction, vacuum). While these interventions often alleviate painful erections, only a small number of patients experience substantial straightening. In later stages or for more severe cases, surgery aims to correct the curvature and restore satisfactory sexual function (2). Platelets, beyond their well-known hemostatic function, are pivotal in tissue regeneration. Once activated following injury, they release proteins and signaling molecules that ignite key healing processes. Platelet-rich plasma (PRP) provides high concentrations of growth factors such as PDGF, TGF-β, VEGF, EGF, IGF, and FGF, all of which aid in tissue repair. Recent advances, including the lyophilization of trehalose-loaded platelets, offer an effective method for storing platelet-derived cytokines at room temperature. This breakthrough allows PRP preparations with bioactive autologous platelets to be preserved for extended periods, expanding their clinical applicability (3-5). Lyophilized platelet-derived growth factors constitute an advanced formulation that differs from traditional PRP by utilizing donor-sourced (allogeneic) platelets rather than patient-derived (autologous) platelets. This refined approach incorporates a precise, standardized quantity of platelets as the growth factor source, in contrast to the variable concentration found in conventional PRP preparations (6). Lyophilized platelet-rich plasma has been investigated in dermatology as in the treatment of striae distensae (7) or female pattern hair loss (8). Also, in the orthopedics such as in the treatment of subacromial impingement syndrome (9) and in the treatment of primary knee osteoarthritis (10). Aim of the work: The aim of this study is to evaluate the effect of intralesional lyophilized Platelet Derived Growth Factors (PDGF) on patients with Peyronie's disease (PD). Study design: Prospective, non- randomized clinical trial. Population of study & disease conditions: Married male patients complaining of either acquired penile curvature or Presence of non-calcified penile plaque. Inclusion criteria: Male patients included in the study will be recruited from Andrology, Sexology & STI's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Presence of non-calcified plaque or acquired penile curvature (i.e Peyronie’s disease) in acute stage as we considered the cases in the acute stage depending on the time of onset of the dieses less than 18 month (11), no calcifications noticed in the ultrasonography and presence of pain. As collagenase clostridium histolyticum is not available in our country we offered the patients the injection of the plaque with lyophilized platelet derived growth factors. Exclusion criteria: Men who had prior medical or surgical treatment for Peyronie's disease. Men who had a history of extracorporeal shock wave therapy (ESWT). Men who had hourglass and hinge deformity or infection at the site of injection. Sample size Sample size calculation was done with alpha error of 5%, power of study 95% & level of confidence was kept at 95%. 42 patients who met the criteria of the study were included in the study. Ethics approval and consent to participate: An informed, written consent has been obtained from all patients who participated in the study. The study has been performed according to the Declaration of Helsinki, and the procedures have been approved by Cairo University - Faculty of Medicine - Ethical Review Committee No. (MD – 210 – 2022) which revised and approved the study protocol & the informed consent. Methodology Forty-two patients were included in the study. They signed an informed consent approved by the internal ethics committee of Kasr Elaini faculty of medicine. Then, they were subjected to complete medical history taking & genital examination. Patients asked to complete sexual health inventory for men questionnaire (SHIM) (12), Erection hardening score self-reported questionnaire & Peyronie's Disease Questionnaire (PDQ). Thereafter, they were subjected to pharmacopenile duplex examination using 20 ug PGE1 where erection grading and PSV, EDV were evaluated using Mindray Z5 duplex device (13). Also, the plaque size was measured according to the longest diameter (mm) and plaque position was assessed as follows: proximal, medial, distal or septal. All penile duplex studies were done by the same doctor. Measurement of angle of penile deviation was done using goniometer stainless steel protractor only in full rigid erection, observed and measured by the doctor and not depending on patient self-reported photography. Preparation of LGF The used LGF was produced according to the European patent number issued in November 2016 by a patented method (5). The platelet concentrate was collected in the blood bank of Cairo Medical Centre Hospital According to manufacturer’s instructions, the platelet concentrate was 1 st tested for hepatitis B vims surface antigen, hepatitis C vims antibodies, human immunodeficiency virus -I and II antibodies and p-24 antigen, and antibodies to Treponema pallidum, by ELISA kits (R & D Systems, Minneapolis, MN, USA) and by PCR (Thermo Fisher Scientific, Boston, MA, USA) and was found to be non-reactive. Then platelet concentrate was treated by the Mirasol® Pathogen Reduction Technology System, (Terumo BCT, Ltd. Tokyo, Japan). In vitro stimulation of platelet concentrates was then performed by incubation with human sterile Thrombin (500 units /mm 3 , Sigma Chemical Co., Munich, FRG) at 37°C for 3 hours resulting in the release of growth factors, cytokines and fibrinogen. The released fibrinogen then formed an insoluble clot that shrank to a negligible size, leaving a fluid platelet releasate. The platelet releasate was then centrifuged for 20 minutes at 1500g and the supernatant was transferred into a new container. The platelet releasate was subjected to a second pathogen concentration reduction step by adding a solvent (tri-n butyl phosphate 0.3% - TNBPC) and detergent system (1% tween 20d) for 1 hour at 31°C to disrupt any enveloped viruses. After that, the solvent and the detergent were removed by three consecutive steps of vegetable-oil extraction. Sterile castor oil (7.5% of total volume) was added to the platelet releasate and the mixture was subjected to shaking on a blood mixer for 15 minutes then the container was suspended in an inverted position for 10 minutes to obtain an upper oil phase and a lower platelet lysate phase, which was separated from upper one by gravity (this step was repeated twice). The platelet releasate was subsequently centrifuged for 20 minutes at 4°C and 1500g, in an inverted position to separate any remnants of oil in an upper phase and the platelet releasate in a lower phase was obtained by gravity. The platelet releasate was then subjected to a sterile filtration step and was divided and dispensed in glass vials in a predetermined volume that was adjusted according to initial platelet counts of concentrate to ensure an equivalent of around 2 million platelets/Pl. The filtrate liquid (containing platelet growth factors) was then subjected to lyophilization (i.e., a freeze-drying or dehydration process) to prolong the shelf-life of the platelet releasate. The final L-GF vials contained a pale-yellow round cake or powder of GFs with a standardized amount in each vial to the equivalent of the product of 2 million platelets/pL, ready for usage or storage at 4°C until use. Just before injection the LGV vial was reconstituted in 2 ml of normal saline. Procedure: The skin was prepped with alcohol swabs followed by an intra-lesional injection of 2 ml of LGF after vial suspension in flaccid state. Direct pressure was applied for 2 minutes (Figure 1). Patients received intra-lesional injections with 6 vials of LGF (lyophilized growth factor), and one vial every two weeks for 12 weeks. Assessment and follow up of plaque size and penile curvature through a Penile duplex with a 1cc PGE1 solution was performed 6 &12 weeks after the first intra-lesional injection with LGF. Assessment of erectile function using SHIM score, Erection hardness score was performed 6 & 12 weeks after the first intra-lesional injection with LGF. At the end of the study patients were asked to answer the Peyronie's Disease Questionnaire (PDQ). Only 4 patients dropped out during the study. Statistical methods: Data was coded and entered using the statistical package for the Social Sciences (SPSS) version 28. Data was summarized using mean and standard deviation in quantitative data and using frequency (count) and relative frequency (percentage) for categorical data. Comparisons between groups were done using ANOVA with post hoc test in normally distributed quantitative variables while non-parametric Kruskal-Wallis test and Mann-Whitney test were used for non-normally distributed quantitative variables. For comparison of serial measurements within each group repeated measures ANOVA was used in normally distributed quantitative variables while non-parametric Friedman test and Wilcoxon signed rank test were used for non-normally distributed quantitative variables. P-values less than 0.05 were considered statistically significant. Results 42 male subjects, who met the inclusion criteria were included in the study, with mean age was 52.83 (23-78) attending the outpatient clinic of Andrology, Kasr El Aini Hospital, Cairo University. Only four patients dropped out at follow-up. No patients were excluded from the study because no serious side effects or worsening of symptoms were observed during the protocol. Sixteen patients (38.1%) had Diabetes (DM), six patients (14.3%) had hypertension (HTN) and fourteen patients (33.3%) were smokers (Table 1). Nineteen patients (45.23%) presented with penile curvature, four patients (9.52%) presented with ED, thirteen patients (30.95%) presented with penile lump accompanied with penile pain and Six patients (14.3%) presented with mixed complaints (Table 2). Curvature was ventral in twelve (28.6%) patients, dorsal in five (11.9%) patients, left in seven (16.7%) patients and right in two (4.8%) patients. Sixteen patients (38.1%) had no curvature. By clinical examination in seventeen (40.5%) patients’ plaque was felt in proximal third of the penis, while in nineteen (45.2%) patients it was felt in middle third and in only six (14.3%) it was felt in distal third. By penile duplex, plaque in twenty-seven (64.3%) patients was located dorsal, while in ten (23.8%) patients was located lateral and in only Five (11.9%) patients was located ventral (table 3). Before injection there were six (14.3%) patients with E2 response and twenty-four (57.1%) patients with E3 response. After the injection there was no E2 response, 24 out of 38 patients showed improved response to ICI (table 4). The average plaque size before treatment was 2.70 ± 0.87 cm, and after treatment, this value significantly decreased to 1.43 ± 0.44 cm ( P value < 0.001). Plaque size did not increase for any of the patients after treatment (table 5). The mean curvature angle was 34.62 ± 16.37 degrees before treatment, whereas this value decreased to 19.40 ± 12.44 degrees after six weeks of treatment. The mean curvature angle significantly decreased after twelve weeks of treatment to 11.40 ± 8.84 degrees ( P value < 0.001) (table 6). The average SHIM score before treatment was (20.57 ± 3.9). while after injection there was statistically significant difference as this score increased to (22.50 ± 1.54) after twelve weeks of treatment with ( P value < 0.002) (table 7). The PDQ score was 12.71 ± 4.50 (5-22) on average for domain 1, and this value decreased significantly to 3.53 ± 3.16 (0-12) after treatment ( P value < 0.001). The PDQ score average was 17.74 ± 4.17 (9-25) for domain 2 before treatment and significantly decreased to 3.00 ± 3.68 (0-18) after treatment ( P value < 0.001). Finally, the PDQ score for domain 3 decreased significantly after treatment, as did the other scores. Before treatment, this value was 10.62 ± 2.34 (5-14), and after treatment, it was 2.32 ± 1.83 (0-8) ( P value < 0.001) (Figure 2). No side effects were noticed during the duration of the study such as pain, bruises or infection. Discussion Today, the most effective acute phase treatment is provided with collagenase clostridium histolyticum. This is the only treatment method licensed by the FDA (14-17). However, especially in developing countries, using this agent can be very costly and the procurement of the drug can be difficult. Based on currently available scientific evidence, the intralesional agent presenting the optimal benefit-risk ratio is far from determined, and further research of novel intralesional agents is strongly needed. As far as we know, this study is the first research to consider intralesional lyophilized Platelet Derived Growth Factors (PDGF) in the treatment of Peyronie's Disease. Several studies have examined the effectiveness of platelet-rich plasma (PRP) injections for treating Peyronie’s disease (PD). Culha et al. (2019) investigated intralesional PRP on a TGF-β1-induced rat model and reported no therapeutic benefit (18). Conversely, Matz et al. (2018) examined PRP injections in 17 PD patients (average of 2.1 injections per patient), finding a 4.14-point increase in IIEF scores (80% of patients showed improvement) and subjective curvature improvements in 80% (19). In comparison, the current study involved 38 patients (average of 6 injections), yielding a 1.93-point increase in SHIM scores and a mean reduction in curvature from 34.62° to 11.40°. Erection Hardness Score (EHS) also improved, with no patients remaining at E1 or E2 after treatment. Virag et al. (2016) used PRP combined with HA in 90 patients, noting an 18.08° reduction in curvature over two months, enhanced erection quality, improved sexual activity, and minimal adverse events (e.g., ecchymosis in 16.7% and hematoma in 10%) (20). In comparison, the current study observed a mean 23.22° curvature reduction, an IIEF increase from 20.57±3.9 to 22.50±1.54, and no complications. Notsek and Boiko in (2019) divided 59 patients into two groups: 32 receiving intralesional PRP and 27 receiving 0.9% sodium chloride. Fifty percent of the PRP group and 22.2% of the control group showed improvements in curvature. Regarding erectile dysfunction, IIEF-5 scores increased in 56.3% of the PRP group versus 3.7% in the control group (21). The current study found a 23.22° average reduction in curvature and a 23.8% increase in IIEF-5 scores, likely lower due to a smaller sample size and a relatively high baseline IIEF. Pain also improved by 60%, versus 84% reported by Notsek and Boiko (21). Achraf et al. in (2022) documented a 17.07° mean improvement in curvature and a 55.5% increase in IIEF-5 scores (22). Our study surpassed that with a 23.22° mean curvature reduction but showed a 23.8% IIEF-5 improvement rate. Complications were minimal. Schirmann et al. (2022) found an 11.8° reduction in curvature, alongside significant enhancements in three PDQ questionnaire domains and a 5-point IIEF-EF gain after six months (23). Comparatively, the current study recorded a 23.22° reduction in curvature and improvements of 9.18, 14.74, and 8.3 in the three PDQ domains. Additionally, plaque size significantly decreased from 2.70±0.87 cm to 1.43±0.44 cm, with no patients experiencing plaque enlargement during follow-up. Overall, these findings suggest that intralesional PRP may offer valuable benefits in reducing curvature, improving erectile function, and shrinking plaque size in Peyronie’s disease. Study limitations: The main limitation of the current study was the low number of patients. Additionally, it is not a placebo-controlled randomized study. Additional double-blind randomized placebo-controlled studies are mandated to assess its efficacy in a shame-controlled manner. Another limitation is that the study was not listed with a clinical registration entity. Conclusion Findings of intralesional usage of lyophilized Platelet Derived Growth Factors preliminary in cases with Peyronie’s disease suggest a potential role for the treatment. It is economical, reproducible, and easy to obtain Declarations Funds: There were no funds Author Contribution I.A.: Conceptualization, Investigation, Methodology, Supervision, Writing - original draft Writing - review & editing. A.A.: Conceptualization, Methodology, Supervision, Writing - review & editing; M.E.: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Writing - review & editing. H.F.: Formal analysis. Investigation, Resources, Writing - review & editing. A.Z.: Data curation, Formal analysis, Investigation, Software, Writing - review & editing. A.A.: Data curation, Validation, Writing - review & editing. A.A.: Conceptualization, Data curation, Investigation, Methodology, Supervision, Validation, Writing - original draft, Writing - review & editing. All authors read and approved of the final manuscript. M.A: Conceptualization, Investigation, Methodology, Supervision, Writing - original draft Writing - review & editing. References Abdel Raheem A, Johnson M, Ralph D, Garaffa G. Collagenase clostridium histolyticum: a novel medical treatment for Peyronie's disease. Minerva Urol Nefrol. 2018;70(4):380–5. Chernylovskyi VA, Krakhotkin DV, Chaikovskyi VP. Non-Surgical Treatment of Peyronie's Disease: A Comprehensive Review. Wiad Lek. 2021;74(3 cz 1):539–45. Pan L, Yong Z, Yuk KS, Hoon KY, Yuedong S, Xu J. Growth Factor Release from Lyophilized Porcine Platelet-Rich Plasma: Quantitative Analysis and Implications for Clinical Applications. Aesthetic Plast Surg. 2016;40(1):157–63. Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011;121(4):176–80. Fahmy HM. inventorA method for preparing a growth factors containing platelet releasate2018. Kieb M, Sander F, Prinz C, Adam S, Mau-Moller A, Bader R, et al. Platelet-Rich Plasma Powder: A New Preparation Method for the Standardization of Growth Factor Concentrations. Am J Sports Med. 2017;45(4):954–60. Abdallah M, Fahmy H, Abdel Hameed S, Mostafa AE. Ablative fractional CO(2) laser vs lyophilized growth factor intralesional injection vs combination of both modalities for striae distensae treatment. J Cosmet Dermatol. 2021;20(2):472–80. El Samahy MH, Fahmy HM, El Sawaf SI, Mostafa AE. Lyophilized growth factor intralesional injection in female pattern hair loss: A clinical and trichoscopic study. Dermatol Ther. 2021;34(2):e14867. El-Sherif SM, Abdel-Hamid MM, Noureldin J, Fahmy HM, Abdel-Naby HMA. Effectiveness of lyophilized growth factors injection for subacromial impingement syndrome: a prospective randomized double-blind placebo-controlled study. J Orthop Surg Res. 2023;18(1):78. El-Gohary R, Diab A, El-Gendy H, Fahmy H, Gado KH. Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study. Regen Med. 2021;16(2):113–5. Sandean DP, Leslie SW, Lotfollahzadeh S. Peyronie Disease. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Stephen Leslie declares no relevant financial relationships with ineligible companies. Disclosure: Saran Lotfollahzadeh declares no relevant financial relationships with ineligible companies.2025. Shamloul R, Ghanem H, Abou-zeid A. Validity of the Arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res. 2004;16(5):452–5. Sikka SC, Hellstrom WJ, Brock G, Morales AM. Standardization of vascular assessment of erectile dysfunction: standard operating procedures for duplex ultrasound. J Sex Med. 2013;10(1):120–9. Capece M, Cocci A, Russo G, Cito G, Giubilei G, Cacciamani G, et al. Collagenase clostridium histolyticum for the treatment of Peyronie's disease: a prospective Italian multicentric study. Andrology. 2018;6(4):564–7. Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med. 2017;14(11):1430–7. Abdel Raheem A, Johnson M, Abdel-Raheem T, Capece M, Ralph D. Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. Sex Med Rev. 2017;5(4):529–35. Abdel Raheem A, Capece M, Kalejaiye O, Abdel-Raheem T, Falcone M, Johnson M, et al. Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. BJU Int. 2017;120(5):717–23. Culha MG, Erkan E, Cay T, Yucetas U. The Effect of Platelet-Rich Plasma on Peyronie's Disease in Rat Model. Urol Int. 2019;102(2):218–23. Matz EL, Pearlman AM, Terlecki RP. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59(1):61–5. Virag R, Sussman H. ultrasound guided treatment of peyronie’s disease with plasma rich platelets (PRP) and hyaluronic acid (HA). J Sex Med. 2016;13:S5–6. Notsek M, Boiko M. PO-01-083 Platelet-rich Plasma Therapy of Peyronie's Disease. J Sex Med. 2019;16:Page S70. Achraf C, Abdelghani PA, Jihad PEA. Platelet-rich plasma in patients affected with Peyronie's disease. Arab J Urol. 2023;21(2):69–75. Schirmann A, Boutin E, Faix A, Yiou R. Tolerance and efficacy of platelet-rich plasma injections in Peyronie's disease: Pilot study. Prog Urol. 2022;32(12):856–61. Tables Table (1): Age of the patients & descriptive analysis of risk factors Age (range) years DM HTN BPH Cardiac Smoking 23-73 Count 14 6 2 4 13 Mean 52.8 % 33.3% 14.3% 4.8% 9.4% 31.0% DM = Diabetes mellitus, HTN = Hypertension, BPH = Benign prostatic hyperplasia. Table (2): Descriptive analysis of patients’ presenting symptoms: Curvature Weak erection Penile lump with Penile pain Mixed Count 19 4 13 6 % 45.23% 9.52% 30.95% 14.30% Table (3): Plaque position at the main plane among cases according to clinical Exam and Penile duplex: According to clinical Exam According to Penile duplex Plaque position Proximal Third Middle Third Distal Third Ventral Dorsal Lateral Count 17 19 6 5 27 10 % 40.5% 45.2% 14.3% 11.9% 64.3% 23.8% Table (4): Comparison between EH score before and after treatment: E1 E2 E3 E4 EH score baseline (n=42) 0% 6 (14.3%) 24 (57.1%) 12 (28.6%) EH score after 12 weeks (n=38) 0% 0% 6 (15.8%) 32 (84.2%) Table (5): Comparison between Plaque size before and after treatment by penile duplex: Mean SD Minimum Maximum P value compared to baseline Plaque size in cm baseline 2.70 0.87 1.50 5.20 ---- Plaque size in cm after 6 weeks 1.93 0.63 1.10 3.40 *< 0.001 Plaque size in cm after 12 weeks 1.43 0.44 0.90 2.80 *< 0.001 plaque size cm after 24 weeks 1.43 0.44 0.90 2.80 *< 0.001 Table (6): Comparison between Penile curvature degrees before and after treatment: Mean SD Minimum Maximum P value compared to baseline Curvature degree baseline 34.62 16.37 15.00 80.00 ---- Curvature degree after 6 Weeks 19.40 12.44 5.00 60.00 *0.013 Curvature degree after 12 weeks 11.40 8.84 5.00 45.00 *< 0.001 curvature degree after 24 weeks 11.40 8.84 5.00 45.00 *< 0.001 Table (7): Comparison between SHIM score before and after treatment: Mean SD Minimum Maximum P value compared to baseline SHIM score baseline 20.57 3.90 6.00 24.00 ---- SHIM after 12 weeks 22.50 1.54 17.00 24.00 *0.002 SHIM after 24 weeks 22.61 1.28 18.00 24.00 *0.002 Additional Declarations No competing interests reported. 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University","correspondingAuthor":false,"prefix":"","firstName":"Adham","middleName":"","lastName":"ZaaZaa","suffix":""},{"id":455165983,"identity":"7a64984f-d7fb-448f-97de-5ce10c1a5d94","order_by":5,"name":"Ahmed Adel","email":"","orcid":"","institution":"Cairo University","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"","lastName":"Adel","suffix":""},{"id":455165984,"identity":"c6f4adff-eca3-4458-87db-32f6d079b97c","order_by":6,"name":"Amr Gadalla","email":"","orcid":"","institution":"Cairo University","correspondingAuthor":false,"prefix":"","firstName":"Amr","middleName":"","lastName":"Gadalla","suffix":""},{"id":455165985,"identity":"9e2efad8-e61e-43e8-bec4-1cf00ef86016","order_by":7,"name":"Mohamed AbdElsalam","email":"","orcid":"","institution":"Cairo University","correspondingAuthor":false,"prefix":"","firstName":"Mohamed","middleName":"","lastName":"AbdElsalam","suffix":""}],"badges":[],"createdAt":"2025-04-21 21:23:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6498718/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6498718/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82711518,"identity":"885c8a7f-8dc9-4c43-aa4b-fee2e5a5d288","added_by":"auto","created_at":"2025-05-14 11:33:48","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":104266,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6498718/v1/d7ea36abd56ff72909945477.jpg"},{"id":82712689,"identity":"3cd84082-9c53-47a4-8ca5-a51b01b58045","added_by":"auto","created_at":"2025-05-14 11:41:49","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":67743,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6498718/v1/9d0dae779d98f9f649916d6a.jpg"},{"id":88713683,"identity":"a001fddb-fac3-45b2-9b49-c5bac3e71017","added_by":"auto","created_at":"2025-08-10 08:38:42","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1026422,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6498718/v1/43529423-42ed-4aef-93b8-c6970f904638.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluation of intralesional injection of platelet derived growth factors PDGF ma in patients with Peyronie's disease","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePeyronie’s disease, historically referred to as induratio penis plastica, arises from collagen buildup in the tunica albuginea surrounding the penile corpus cavernosum, forming plaques that can lead to penile shortening and curvature (1). Early-stage management focuses on conservative therapies, including various oral medications (such as vitamin E, para-aminobenzoate, tamoxifen, colchicine, carnitine esters, pentoxifylline), intralesional injection treatments (steroids, verapamil, collagenase, interferon), and topical or device-based options (verapamil, iontophoresis, shock wave therapy, traction, vacuum). While these interventions often alleviate painful erections, only a small number of patients experience substantial straightening. In later stages or for more severe cases, surgery aims to correct the curvature and restore satisfactory sexual function (2).\u003c/p\u003e\n\u003cp\u003ePlatelets, beyond their well-known hemostatic function, are pivotal in tissue regeneration. Once activated following injury, they release proteins and signaling molecules that ignite key healing processes. Platelet-rich plasma (PRP) provides high concentrations of growth factors such as PDGF, TGF-β, VEGF, EGF, IGF, and FGF, all of which aid in tissue repair. Recent advances, including the lyophilization of trehalose-loaded platelets, offer an effective method for storing platelet-derived cytokines at room temperature. This breakthrough allows PRP preparations with bioactive autologous platelets to be preserved for extended periods, expanding their clinical applicability (3-5). Lyophilized platelet-derived growth factors constitute an advanced formulation that differs from traditional PRP by utilizing donor-sourced (allogeneic) platelets rather than patient-derived (autologous) platelets. This refined approach incorporates a precise, standardized quantity of platelets as the growth factor source, in contrast to the variable concentration found in conventional PRP preparations (6). Lyophilized platelet-rich plasma has been investigated in dermatology as in the treatment of striae distensae (7) or female pattern hair loss (8). Also, in the orthopedics such as in the treatment of subacromial impingement syndrome (9) and in the treatment of primary knee osteoarthritis (10).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAim of the work:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe aim of this study is to evaluate the effect of intralesional lyophilized Platelet Derived Growth Factors (PDGF) on patients with Peyronie's disease (PD).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy design:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProspective, non- randomized clinical trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePopulation of study \u0026amp; disease conditions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMarried male patients complaining of either acquired penile curvature or Presence of non-calcified penile plaque.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMale patients included in the study will be recruited from Andrology, Sexology \u0026amp; STI's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Presence of non-calcified plaque or acquired penile curvature (i.e Peyronie’s disease) in acute stage as we considered the cases in the acute stage depending on the time of onset of the dieses less than 18 month (11), no calcifications noticed in the ultrasonography and presence of pain. As collagenase clostridium histolyticum is not available in our country we offered the patients the injection of the plaque with lyophilized platelet derived growth factors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMen who had prior medical or surgical treatment for Peyronie's disease. Men who had a history of extracorporeal shock wave therapy (ESWT). Men who had hourglass and hinge deformity or infection at the site of injection.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSample size calculation was done with alpha error of 5%, power of study 95% \u0026amp; level of confidence was kept at 95%. 42 patients who met the criteria of the study were included in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn informed, written consent has been obtained from all patients who participated in the study. The study has been performed according to the Declaration of Helsinki, and the procedures have been approved by Cairo University - Faculty of Medicine - Ethical Review Committee No. (MD – 210 – 2022) which revised and approved the study protocol \u0026amp; the informed consent.\u0026nbsp;\u003c/p\u003e"},{"header":"Methodology","content":"\u003cp\u003eForty-two patients were included in the study. They signed an informed consent approved by the internal ethics committee of Kasr Elaini faculty of medicine. Then, they were subjected to complete medical history taking \u0026amp; genital examination. Patients asked to complete sexual health inventory for men questionnaire (SHIM) (12), Erection hardening score self-reported questionnaire \u0026amp; Peyronie's Disease Questionnaire (PDQ). Thereafter, they were subjected to pharmacopenile duplex examination using 20 ug PGE1 where erection grading and PSV, EDV were evaluated using Mindray Z5 duplex device (13). Also, the plaque size was measured according to the longest diameter (mm) and plaque position was assessed as follows: proximal, medial, distal or septal. All penile duplex studies were done by the same doctor. Measurement of angle of penile deviation was done using goniometer stainless steel protractor only in full rigid erection, observed and measured by the doctor and not depending on patient self-reported photography.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePreparation of LGF\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe used LGF was produced according to the European patent number issued in November 2016 by a patented method (5). The platelet concentrate was collected in the blood bank of Cairo Medical Centre Hospital According to manufacturer’s instructions, the platelet concentrate was 1\u003csup\u003est\u003c/sup\u003e tested for hepatitis B vims surface antigen, hepatitis C vims antibodies, human immunodeficiency virus -I and II antibodies and p-24 antigen, and antibodies to Treponema pallidum, by ELISA kits (R \u0026amp; D Systems, Minneapolis, MN, USA) and by PCR (Thermo Fisher Scientific, Boston, MA, USA) and was found to be non-reactive. Then platelet concentrate was treated by the Mirasol® Pathogen Reduction Technology System, (Terumo BCT, Ltd. Tokyo, Japan). In vitro stimulation of platelet concentrates was then performed by incubation with human sterile Thrombin (500 units /mm\u003csup\u003e3\u003c/sup\u003e, Sigma Chemical Co., Munich, FRG) at 37°C for 3 hours resulting in the release of growth factors, cytokines and fibrinogen. The released fibrinogen then formed an insoluble clot that shrank to a negligible size, leaving a fluid platelet releasate. The platelet releasate was then centrifuged for 20 minutes at 1500g and the supernatant was transferred into a new container. The platelet releasate was subjected to a second pathogen concentration reduction step by adding a solvent (tri-n butyl phosphate 0.3% - TNBPC) and detergent system (1% tween 20d) for 1 hour at 31°C to disrupt any enveloped viruses. After that, the solvent and the detergent were removed by three consecutive steps of vegetable-oil extraction. Sterile castor oil (7.5% of total volume) was added to the platelet releasate and the mixture was subjected to shaking on a blood mixer for 15 minutes then the container was suspended in an inverted position for 10 minutes to obtain an upper oil phase and a lower platelet lysate phase, which was separated from upper one by gravity (this step was repeated twice). The platelet releasate was subsequently centrifuged for 20 minutes at 4°C and 1500g, in an inverted position to separate any remnants of oil in an upper phase and the platelet releasate in a lower phase was obtained by gravity. The platelet releasate was then subjected to a sterile filtration step and was divided and dispensed in glass vials in a predetermined volume that was adjusted according to initial platelet counts of concentrate to ensure an equivalent of around 2 million platelets/Pl. The filtrate liquid (containing platelet growth factors) was then subjected to lyophilization (i.e., a freeze-drying or dehydration process) to prolong the shelf-life of the platelet releasate. The final L-GF vials contained a pale-yellow round cake or powder of GFs with a standardized amount in each vial to the equivalent of the product of 2 million platelets/pL, ready for usage or storage at 4°C until use. Just before injection the LGV vial was reconstituted in 2 ml of normal saline.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedure:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe skin was prepped with alcohol swabs followed by an intra-lesional injection of 2 ml of LGF after vial suspension in flaccid state. Direct pressure was applied for 2 minutes (Figure 1). Patients received intra-lesional injections with 6 vials of LGF (lyophilized growth factor), and one vial every two weeks for 12 weeks. Assessment and follow up of plaque size and penile curvature through a Penile duplex with a 1cc PGE1 solution was performed 6 \u0026amp;12 weeks after the first intra-lesional injection with LGF. Assessment of erectile function using SHIM score, Erection hardness score was performed 6 \u0026amp; 12 weeks after the first intra-lesional injection with LGF. At the end of the study patients were asked to answer the Peyronie's Disease Questionnaire (PDQ). Only 4 patients dropped out during the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData was coded and entered using the statistical package for the Social Sciences (SPSS) version 28. Data was summarized using mean and standard deviation in quantitative data and using frequency (count) and relative frequency (percentage) for categorical data. Comparisons between groups were done using ANOVA with post hoc test in normally distributed quantitative variables while non-parametric Kruskal-Wallis test and Mann-Whitney test were used for non-normally distributed quantitative variables. For comparison of serial measurements within each group repeated measures ANOVA was used in normally distributed quantitative variables while non-parametric Friedman test and Wilcoxon signed rank test were used for non-normally distributed quantitative variables. P-values less than 0.05 were considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e42 male subjects, who met the inclusion criteria were included in the study, with mean age was 52.83 (23-78) attending the outpatient clinic of Andrology, Kasr El Aini Hospital, Cairo University. Only four patients dropped out at follow-up. No patients were excluded from the study because no serious side effects or worsening of symptoms were observed during the protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSixteen patients (38.1%) had Diabetes (DM), six patients (14.3%) had hypertension (HTN) and fourteen patients (33.3%) were smokers (Table 1). Nineteen patients (45.23%) presented with penile curvature, four patients (9.52%) presented with ED, thirteen patients (30.95%) presented with penile lump accompanied with penile pain and Six patients (14.3%) presented with mixed complaints (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCurvature was ventral in twelve (28.6%) patients, dorsal in five (11.9%) patients, left in seven (16.7%) patients and right in two (4.8%) patients. Sixteen patients (38.1%) had no curvature. By clinical examination in seventeen (40.5%) patients’ plaque was felt in proximal third of the penis, while in nineteen (45.2%) patients it was felt in middle third and in only six (14.3%) it was felt in distal third. By penile duplex, plaque in twenty-seven (64.3%) patients was located dorsal, while in ten (23.8%) patients was located lateral and in only Five (11.9%) patients was located ventral (table 3). \u0026nbsp;Before injection there were six (14.3%) patients with E2 response and twenty-four (57.1%) patients with E3 response. After the injection there was no E2 response, 24 out of 38 patients showed improved response to ICI (table 4).\u003c/p\u003e\n\u003cp\u003eThe average plaque size before treatment was 2.70 ± 0.87 cm, and after treatment, this value significantly decreased to 1.43 ± 0.44 cm (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.001). Plaque size did not increase for any of the patients after treatment (table 5). The mean curvature angle was 34.62 ± 16.37 degrees before treatment, whereas this value decreased to 19.40 ± 12.44 degrees after six weeks of treatment. The mean curvature angle significantly decreased after twelve weeks of treatment to 11.40 ± 8.84 degrees (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.001) (table 6).\u003c/p\u003e\n\u003cp\u003eThe average SHIM score before treatment was (20.57 ± 3.9). while after injection there was statistically significant difference as this score increased to (22.50 ± 1.54) after twelve weeks of treatment with (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.002) (table 7). The PDQ score was 12.71 ± 4.50 (5-22) on average for domain 1, and this value decreased significantly to 3.53 ± 3.16 (0-12) after treatment (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.001). The PDQ score average was 17.74 ± 4.17 (9-25) for domain 2 before treatment and significantly decreased to 3.00 ± 3.68 (0-18) after treatment (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.001). Finally, the PDQ score for domain 3 decreased significantly after treatment, as did the other scores. Before treatment, this value was 10.62 ± 2.34 (5-14), and after treatment, it was 2.32 ± 1.83 (0-8) (\u003cstrong\u003e\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u003c/strong\u003evalue \u0026lt; 0.001) (Figure 2). No side effects were noticed during the duration of the study such as pain, bruises or infection.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eToday, the most effective acute phase treatment is provided with collagenase clostridium histolyticum. This is the only treatment method licensed by the FDA \u0026nbsp;(14-17). However, especially in developing countries, using this agent can be very costly and the procurement of the drug can be difficult.\u003c/p\u003e\n\u003cp\u003eBased on currently available scientific evidence, the intralesional agent presenting the optimal benefit-risk ratio is far from determined, and further research of novel intralesional agents is strongly needed. As far as we know, this study is the first research to consider intralesional lyophilized Platelet Derived Growth Factors (PDGF) in the treatment of Peyronie's Disease.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSeveral studies have examined the effectiveness of platelet-rich plasma (PRP) injections for treating Peyronie’s disease (PD). Culha et al. (2019) investigated intralesional PRP on a TGF-β1-induced rat model and reported no therapeutic benefit (18). Conversely, Matz et al. (2018) examined PRP injections in 17 PD patients (average of 2.1 injections per patient), finding a 4.14-point increase in IIEF scores (80% of patients showed improvement) and subjective curvature improvements in 80% (19). In comparison, the current study involved 38 patients (average of 6 injections), yielding a 1.93-point increase in SHIM scores and a mean reduction in curvature from 34.62° to 11.40°. Erection Hardness Score (EHS) also improved, with no patients remaining at E1 or E2 after treatment.\u003c/p\u003e\n\u003cp\u003eVirag et al. (2016) used PRP combined with HA in 90 patients, noting an 18.08° reduction in curvature over two months, enhanced erection quality, improved sexual activity, and minimal adverse events (e.g., ecchymosis in 16.7% and hematoma in 10%) (20). In comparison, the current study observed a mean 23.22° curvature reduction, an IIEF increase from 20.57±3.9 to 22.50±1.54, and no complications. Notsek and Boiko in (2019) divided 59 patients into two groups: 32 receiving intralesional PRP and 27 receiving 0.9% sodium chloride. Fifty percent of the PRP group and 22.2% of the control group showed improvements in curvature. Regarding erectile dysfunction, IIEF-5 scores increased in 56.3% of the PRP group versus 3.7% in the control group (21). The current study found a 23.22° average reduction in curvature and a 23.8% increase in IIEF-5 scores, likely lower due to a smaller sample size and a relatively high baseline IIEF. Pain also improved by 60%, versus 84% reported by Notsek and Boiko (21).\u003c/p\u003e\n\u003cp\u003eAchraf et al. in (2022) documented a 17.07° mean improvement in curvature and a 55.5% increase in IIEF-5 scores (22). Our study surpassed that with a 23.22° mean curvature reduction but showed a 23.8% IIEF-5 improvement rate. Complications were minimal. Schirmann et al. (2022) found an 11.8° reduction in curvature, alongside significant enhancements in three PDQ questionnaire domains and a 5-point IIEF-EF gain after six months (23). Comparatively, the current study recorded a 23.22° reduction in curvature and improvements of 9.18, 14.74, and 8.3 in the three PDQ domains.\u003c/p\u003e\n\u003cp\u003eAdditionally, plaque size significantly decreased from 2.70±0.87 cm to 1.43±0.44 cm, with no patients experiencing plaque enlargement during follow-up. Overall, these findings suggest that intralesional PRP may offer valuable benefits in reducing curvature, improving erectile function, and shrinking plaque size in Peyronie’s disease.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy limitations:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main limitation of the current study was the low number of patients. Additionally, it is not a placebo-controlled randomized study. Additional double-blind randomized placebo-controlled studies are mandated to assess its efficacy in a shame-controlled manner. Another limitation is that the study was not listed with a clinical registration entity.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eFindings of intralesional usage of lyophilized Platelet Derived Growth Factors preliminary in cases with Peyronie’s disease suggest a potential role for the treatment. It is economical, reproducible, and easy to obtain\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eFunds:\u003c/strong\u003e \u003cp\u003eThere were no funds\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eI.A.: Conceptualization, Investigation, Methodology, Supervision, Writing - original draft Writing - review \u0026amp; editing. A.A.: Conceptualization, Methodology, Supervision, Writing - review \u0026amp; editing; M.E.: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Writing - review \u0026amp; editing. H.F.: Formal analysis. Investigation, Resources, Writing - review \u0026amp; editing. A.Z.: Data curation, Formal analysis, Investigation, Software, Writing - review \u0026amp; editing. A.A.: Data curation, Validation, Writing - review \u0026amp; editing. A.A.: Conceptualization, Data curation, Investigation, Methodology, Supervision, Validation, Writing - original draft, Writing - review \u0026amp; editing. All authors read and approved of the final manuscript. M.A: Conceptualization, Investigation, Methodology, Supervision, Writing - original draft Writing - review \u0026amp; editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAbdel Raheem A, Johnson M, Ralph D, Garaffa G. Collagenase clostridium histolyticum: a novel medical treatment for Peyronie's disease. Minerva Urol Nefrol. 2018;70(4):380\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChernylovskyi VA, Krakhotkin DV, Chaikovskyi VP. Non-Surgical Treatment of Peyronie's Disease: A Comprehensive Review. Wiad Lek. 2021;74(3 cz 1):539\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePan L, Yong Z, Yuk KS, Hoon KY, Yuedong S, Xu J. Growth Factor Release from Lyophilized Porcine Platelet-Rich Plasma: Quantitative Analysis and Implications for Clinical Applications. Aesthetic Plast Surg. 2016;40(1):157\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011;121(4):176\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFahmy HM. inventorA method for preparing a growth factors containing platelet releasate2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKieb M, Sander F, Prinz C, Adam S, Mau-Moller A, Bader R, et al. Platelet-Rich Plasma Powder: A New Preparation Method for the Standardization of Growth Factor Concentrations. Am J Sports Med. 2017;45(4):954\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbdallah M, Fahmy H, Abdel Hameed S, Mostafa AE. Ablative fractional CO(2) laser vs lyophilized growth factor intralesional injection vs combination of both modalities for striae distensae treatment. J Cosmet Dermatol. 2021;20(2):472\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl Samahy MH, Fahmy HM, El Sawaf SI, Mostafa AE. Lyophilized growth factor intralesional injection in female pattern hair loss: A clinical and trichoscopic study. Dermatol Ther. 2021;34(2):e14867.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl-Sherif SM, Abdel-Hamid MM, Noureldin J, Fahmy HM, Abdel-Naby HMA. Effectiveness of lyophilized growth factors injection for subacromial impingement syndrome: a prospective randomized double-blind placebo-controlled study. J Orthop Surg Res. 2023;18(1):78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl-Gohary R, Diab A, El-Gendy H, Fahmy H, Gado KH. Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study. Regen Med. 2021;16(2):113\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSandean DP, Leslie SW, Lotfollahzadeh S. Peyronie Disease. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Stephen Leslie declares no relevant financial relationships with ineligible companies. Disclosure: Saran Lotfollahzadeh declares no relevant financial relationships with ineligible companies.2025.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShamloul R, Ghanem H, Abou-zeid A. Validity of the Arabic version of the sexual health inventory for men among Egyptians. Int J Impot Res. 2004;16(5):452\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSikka SC, Hellstrom WJ, Brock G, Morales AM. Standardization of vascular assessment of erectile dysfunction: standard operating procedures for duplex ultrasound. J Sex Med. 2013;10(1):120\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCapece M, Cocci A, Russo G, Cito G, Giubilei G, Cacciamani G, et al. Collagenase clostridium histolyticum for the treatment of Peyronie's disease: a prospective Italian multicentric study. Andrology. 2018;6(4):564\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRalph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med. 2017;14(11):1430\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbdel Raheem A, Johnson M, Abdel-Raheem T, Capece M, Ralph D. Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. Sex Med Rev. 2017;5(4):529\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbdel Raheem A, Capece M, Kalejaiye O, Abdel-Raheem T, Falcone M, Johnson M, et al. Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. BJU Int. 2017;120(5):717\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCulha MG, Erkan E, Cay T, Yucetas U. The Effect of Platelet-Rich Plasma on Peyronie's Disease in Rat Model. Urol Int. 2019;102(2):218\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatz EL, Pearlman AM, Terlecki RP. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59(1):61\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVirag R, Sussman H. ultrasound guided treatment of peyronie\u0026rsquo;s disease with plasma rich platelets (PRP) and hyaluronic acid (HA). J Sex Med. 2016;13:S5\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNotsek M, Boiko M. PO-01-083 Platelet-rich Plasma Therapy of Peyronie's Disease. J Sex Med. 2019;16:Page S70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAchraf C, Abdelghani PA, Jihad PEA. Platelet-rich plasma in patients affected with Peyronie's disease. Arab J Urol. 2023;21(2):69\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchirmann A, Boutin E, Faix A, Yiou R. Tolerance and efficacy of platelet-rich plasma injections in Peyronie's disease: Pilot study. Prog Urol. 2022;32(12):856\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable (1): Age of the patients \u0026amp; descriptive analysis of risk factors\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2986%;\"\u003e\n \u003cp\u003eAge (range) years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10.2729%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003eDM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003eHTN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003eBPH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003eCardiac\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003eSmoking\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2986%;\"\u003e\n \u003cp\u003e23-73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10.2729%;\"\u003e\n \u003cp\u003eCount\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2986%;\"\u003e\n \u003cp\u003eMean 52.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10.2729%;\"\u003e\n \u003cp\u003e%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e33.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e14.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e4.8%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e9.4%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2857%;\"\u003e\n \u003cp\u003e31.0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eDM = Diabetes mellitus, HTN = Hypertension, BPH = Benign prostatic hyperplasia.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eTable (2): Descriptive analysis of patients\u0026rsquo; presenting symptoms:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"624\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 11.5385%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.6346%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCurvature\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 21.6346%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWeak erection\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32.5321%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePenile lump with Penile pain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.6603%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMixed\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 11.5385%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCount\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 26.7628%;\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16.5064%;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32.5321%;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.6603%;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 11.5385%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 26.7628%;\"\u003e\n \u003cp\u003e45.23%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16.5064%;\"\u003e\n \u003cp\u003e9.52%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32.5321%;\"\u003e\n \u003cp\u003e30.95%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.6603%;\"\u003e\n \u003cp\u003e14.30%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cu\u003eTable (3): Plaque position at the main plane among cases according to clinical Exam and Penile duplex:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"638\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 42.9467%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAccording to clinical Exam\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 42.79%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAccording to Penile duplex\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlaque position\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.4201%;\"\u003e\n \u003cp\u003eProximal Third\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003eMiddle Third\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003eDistal Third\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003eVentral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003eDorsal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003eLateral\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCount\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.4201%;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.4201%;\"\u003e\n \u003cp\u003e40.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e45.2%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e14.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e11.9%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e64.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.2633%;\"\u003e\n \u003cp\u003e23.8%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cu\u003eTable (4): Comparison between EH score before and after treatment:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"625\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.4167%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.1026%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eE1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15.0641%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eE2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2692%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eE3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1474%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eE4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.4167%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEH score baseline (n=42)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.1026%;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15.0641%;\"\u003e\n \u003cp\u003e6 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2692%;\"\u003e\n \u003cp\u003e24 (57.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1474%;\"\u003e\n \u003cp\u003e12 (28.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 35.4167%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEH score after 12 weeks (n=38)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.1026%;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15.0641%;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.2692%;\"\u003e\n \u003cp\u003e6 (15.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1474%;\"\u003e\n \u003cp\u003e32 (84.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cu\u003eTable (5): Comparison between Plaque size before and after treatment by penile duplex:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"105%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 25.7732%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9.27835%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMinimum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMaximum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 20.6186%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP value compared to baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 25.7732%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlaque size in cm baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9.27835%;\"\u003e\n \u003cp\u003e2.70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.87\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e1.50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e5.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 20.6186%;\"\u003e\n \u003cp\u003e----\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 25.7732%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlaque size in cm after 6 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9.27835%;\"\u003e\n \u003cp\u003e1.93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e1.10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e3.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 20.6186%;\"\u003e\n \u003cp\u003e*\u0026lt; 0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 25.7732%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlaque size in cm after 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9.27835%;\"\u003e\n \u003cp\u003e1.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e2.80\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 20.6186%;\"\u003e\n \u003cp\u003e*\u0026lt; 0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 25.7732%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eplaque size cm\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eafter 24 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9.27835%;\"\u003e\n \u003cp\u003e1.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e0.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e2.80\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 20.6186%;\"\u003e\n \u003cp\u003e*\u0026lt; 0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cu\u003eTable (6): Comparison between Penile curvature degrees before and after treatment:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 34.0206%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMinimum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMaximum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP value compared to baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 34.0206%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCurvature degree baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e34.62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e16.37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e15.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e80.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e----\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 34.0206%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCurvature degree after 6 Weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e19.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e12.44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e5.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e60.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e*0.013\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 34.0206%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCurvature degree after 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e11.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e8.84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e5.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e45.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e*\u0026lt; 0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 34.0206%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ecurvature degree after 24 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e11.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e8.84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e5.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e45.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e*\u0026lt; 0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cu\u003eTable (7): Comparison between SHIM score before and after treatment:\u003c/u\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 29.8969%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMinimum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMaximum\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 17.5258%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP value compared to baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 29.8969%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSHIM score baseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e20.57\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e3.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e6.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e24.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 17.5258%;\"\u003e\n \u003cp\u003e----\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 29.8969%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSHIM after 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e22.50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e1.54\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e17.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e24.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.5258%;\"\u003e\n \u003cp\u003e*0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 29.8969%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSHIM after 24 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e22.61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11.3402%;\"\u003e\n \u003cp\u003e1.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 14.433%;\"\u003e\n \u003cp\u003e18.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 15.4639%;\"\u003e\n \u003cp\u003e24.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.5258%;\"\u003e\n \u003cp\u003e*0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Lyophilized Platelet Derived Growth Factors (PDGF), Peyronie’s disease, Plaque, Penile curvature","lastPublishedDoi":"10.21203/rs.3.rs-6498718/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6498718/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePlatelets which are the storage pool of growth factors, when they interact with exposed endothelium within wounds or the damaged tissue, these factors are released and work together in harmony with tissue-repair mechanisms such as chemotaxis, angiogenesis cell proliferation, extracellular matrix deposition, and remodeling to promote appropriate wound healing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAim:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo evaluate the effect of the effect of intralesional lyophilized Platelet Derived Growth Factors (PDGF) in patients with Peyronie's disease (PD).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients and methods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was carried out on 42 patients that were recruited in the period from June 2022 till October 2023 with four patients lost at follow-up. An informed consent was taken, and the followings were done history taking, physical examination, Sexual health inventory for men (SHIM), Erection Hardness Score (EHS), Peyronie's Disease Questionnaire (PDQ), intracorporeal injection and penile duplex. All Patients received intra-lesional injections with 6 vials of LGF (lyophilized growth factor), one vial every two weeks for 12 weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcome:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAssessment and follow up of plaque size and penile curvature through a Penile duplex with a 1cc PGE1 (20 micrograms) solution was performed 6 \u0026amp; 12 weeks after the first intra-lesional injection with LGF.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study showed a significant decrease in the angle of curvature by 23.22° with a mean curvature angle 34.62° ± 16.37° before treatment, and 11.40° ± 8.84° after end of injections. It also showed statistically significant improvement in plaque size with average plaque size before treatment 2.70 ± 0.87 cm, which significantly decreased to 1.43 ± 0.44 cm. In addition, PDQ questionnaire showed a respective improvement of 9.18 points for domain 1, 14.74 for domain 2 and 8.3 for domain 3. Regarding EHS before injection there was two patients with E1 response, six patients with E2 response, while After injection there was no E1or E2 response.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical implications:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInjection of LGF can result in improvement of early cases of Peyronie's disease.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrengths \u0026amp; Limitations:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt is the first study objectively the effect of LGF as a line of treatment of early cases of Peyronie's disease. Additional studies are mandated to assess its efficacy in a shame-controlled manner.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFindings of intralesional usage of lyophilized Platelet Derived Growth Factors preliminary in cases with Peyronie’s disease suggest a potential role for the treatment.\u003c/p\u003e","manuscriptTitle":"Evaluation of intralesional injection of platelet derived growth factors PDGF ma in patients with Peyronie's disease","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-14 11:33:44","doi":"10.21203/rs.3.rs-6498718/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"21170cfa-71d3-4d48-9709-9c98b7d59529","owner":[],"postedDate":"May 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-10T08:38:13+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-14 11:33:44","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6498718","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6498718","identity":"rs-6498718","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}