Рандомизированное контролируемое клиническое исследование по изучению аутоплазмы, обогащенной тромбоцитарными факторами роста, и экстракорпоральной ударноволновой терапии в лечении болезни Пейрони
Background: The results of conservative methods of treating Peyronie’s disease (PD) do not exceed the placebo effect, and surgical treatment does not always lead to satisfactory outcomes. Aim: to evaluate the safety and effectiveness of using platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) in patients with PD. Materials and Methods: The study included 40 patients with PD, randomly assigned into two equal groups. Group 1 received ESWT (Dornier Medtech GmbH, Germany, D82234 Wessling, 62 Argelsrieder Feld, 7, Germany (FSZ 2011/09554) on the penis, targeting the fibrotic areas and calcifications twice weekly for 6 weeks. Group 2 underwent 2 visits per week for 6 weeks. Visit 1 involved PRP injections and ESWT on the penis, fibrotic areas, and calcifications. Visit 2 included only ESWT on the same areas. Outcomes were assessed on days 0 and 60 (median (IQR%)) using the Peyronie’s Disease Questionnaire (PDQ), Visual Analog Scale (VAS) during sexual intercourse and erection, penile curvature angle, plaque size, and calcifications based on penile ultrasound. Results: the treatment was well tolerated by all patients. No side effects were recorded. In group 2, one patient experienced disease progression, developing a «hourglass» deformity of the penis. Both groups showed significant reductions in pain and PD symptoms, as measured by VAS during erection (p = 0.001028, p < 0.001) and VAS during sexual intercourse (p = 0.01604, p < 0.001), as well as improvement in PDQ scores (p < 0.001, p < 0.001). The penile curvature angle also significantly decreased in both groups (p = 0.02364, p = 0.007346). While the size and number of calcifications decreased slightly (p > 0.05), the fibrotic plaque area showed significant regression in both groups (p = 0.001929, p = 0.003188). Post-treatment analysis showed a significant difference in plaque size reduction, VAS during erection, and during sexual intercourse in favor of patients who received APGF in combination with ESWT (p < 0.05). Conclusion: PRP and ESWT may represent a promising conservative strategy for treating PD. Combined therapy of APGF and ESWT is more effective in reducing pain and fibrotic plaque size in the penis compared to ESWT alone. Keywords: Peyronie’s disease, platelet rich plasma, extracorporeal shock wave therapy, growth factors, regenerative medicine, erectile dysfunction.
- Research Article
20
- 10.1016/j.sxmr.2019.02.001
- Mar 26, 2019
- Sexual Medicine Reviews
Peyronie's disease is an acquired condition of the connective tissue of the penis that affects 0.5-20.3% of the male population and is marked by fibrotic plaques in the tunica albuginea. It can result in penile curvature/deviation, painful erections, and sexual dysfunction. Several treatment modalities have been proposed, with studies from the past decade investigating extracorporeal shockwave therapy's (ESWT) potential efficacy in Peyronie's management. To investigate the effects of ESWT on Peyronie's disease parameters such as penile curvature, plaque size, erectile function, and penile pain. We reviewed the literature examining the effects of ESWT on Peyronie's disease. The main outcome measures after receiving extracoporeal shockwave therapy included changes in degree of penile curvature, penile plaque size, International Index of Erectile Function-5 questionnaire score, and visual analogue scale score. Randomized controlled trials examining the efficacy of ESWT in Peyronie's disease do not show a statistically significant benefit in curvature reduction, plaque size, or erectile function, although a recent meta-analysis demonstrates a benefit in plaque size reduction. A statistically significant reduction in penile pain has been observed across multiple studies. Extracorporeal shockwave therapy may be beneficial in the management of Peyronie's disease for refractory penile pain and plaque size reduction. However, penile pain typically resolves spontaneously over time, and shockwave therapy can pose a substantial financial burden to patients. A multi-institutional randomized controlled trial with standardization of methods and strict inclusion criteria regarding disease duration would prove beneficial in determining the true efficacy of shockwave therapy in Peyronie's disease. Krieger JR, Rizk PJ, Kohn TP, etal. Shockwave Therapy in the Treatment of Peyronie's Disease. Sex Med Rev 2019;7:499-507.
- Research Article
19
- 10.4103/0974-7796.192100
- Jan 1, 2016
- Urology annals
Introduction:Peyronie's Disease (PD) is a disease causing psycho social trauma to the patient. Multiple treatment options are available with variable results. Extra Corporeal Shock Wave Therapy (ESWT) is a new insight into the non invasive modality of management. It focuses on the mechanism of inducing angiogenesis in the penile cavernous tissue.Materials and Methods:The aim of the study is to determine the role of ESWT in the management of PD. The objectives include demonstrating the improvement in mean International Index of Erectile Function Score (IIEFS), improvement in pain score by Visual Analogue Scale (VAS), change in cavernosal artery flow on colour penile Doppler, reduction in plaque size, and improvement in penile curvature degree after the therapy. 30 patients, between 25-65 years, who were non responders to conservative line of management, were treated with ESWT. The results were evaluated at baseline and 18-24 weeks after the therapy.Results:ESWT significantly improves the cavernosal artery velocity, thereby supporting the theory of angiogenesis. ESWT improves all the domains of IIEF including Erectile Function, Sexual Desire, Sexual Satisfaction, Orgasm and Overall Satisfaction. There is a significant improvement in the pain and penile curvature, and reduction in the plaque size. No adverse effects have been recorded.Conclusion:ESWT offers a safe, minimally invasive, OPD based option to the management of the patients of PD in the stable phase of the disease. Patients who do not respond to the conservative line of management can be really benefited by ESWT.
- Research Article
101
- 10.1111/j.1365-2605.2011.01226.x
- Nov 15, 2011
- International journal of andrology
Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction.
- Research Article
20
- 10.1016/j.jsxm.2021.06.012
- Sep 10, 2021
- The journal of sexual medicine
Extracorporeal Shockwave Therapy in Peyronie's Disease: Systematic Review and Meta-Analysis
- Research Article
- 10.1177/039156030907604s17
- Jan 1, 2009
- Urologia Journal
Introduction Extracorporeal Shock Wave Therapy (ESWT) is a minimal invasive treatment for patients with Peyronie's Disease (PD). Currently, however, controversial data exist on the efficacy of ESWT as first-line treatment. Methods We performed a prospective, randomized, double blind, placebo-controlled trial to evaluate the efficacy of ESWT in a group of 100 patients with disease duration <12 months, naive to previous treatments, with a single plaque, erectile dysfunction and/or painful erections and/or penile recurvatum. Patients were randomized to undergo ESWT or Placebo. The Storz Duolith device was employed for treatments. A non-functioning probe was employed as placebo. Treatments were administered in four sessions at weekly intervals. The following evaluations were performed at baseline and at 12- and 24-week intervals from treatment: IIEF-5 (International Index of Erectile Function) questionnaire, VAS (Visual Analogue Scale), plaque size measurement, penile curvature measurement. Results Only patients treated with ESWT reported a significant improvement of mean VAS score and of mean IIEF-5 score at a 12-week follow-up. Mean plaque size and mean curvature degree did not improved significantly in patients treated with ESWT but showed a significant worsening at the 24-week follow up compared to baseline values in the placebo group. Conclusions ESWT can improve significantly painful erections and erectile functions in patients with PD naive to other treatments. Moreover, ESWT can stabilize plaque size and penile curvature thus preventing disease progression.
- Research Article
104
- 10.1111/jsm.12275
- Nov 1, 2013
- The Journal of Sexual Medicine
Extracorporeal shock wave therapy (ESWT) for treatment of Peyronie's disease (PD) is controversial. To study the efficacy of ESWT by a placebo-controlled, randomized trial. Patients with PD (n=102) were randomly assigned (n=51) to each group (ESWT or placebo). All patients were given 6 weekly treatments. Patients in the ESWT-group received 2,000 shock waves per session, using the Piezoson 100 lithotripter (Richard Wolf, Knittlingen, Germany). Patients in the placebo-group were treated with interposition of a plastic membrane, which prevented any transmission of shock waves. Primary end point was decrease of pain between baseline and after 4 weeks follow-up. Secondary end points were changes in deviation, plaque size, and sexual function. Pain was assessed by a visual analog scale. Deviation was measured by a goniometer after artificial erection using Alprostadil (Viridal®, Schwarz Pharma, Monheim, Germany). Plaque size was measured with a ruler and sexual function assessed by a scale regarding the ability to perform sexual intercourse. Overall, only 45 patients experienced pain at baseline. In the subgroup analysis of these patients, pain decreased in 17/20 (85.0%) patients in the ESWT group and 12/25 (48.0%) patients in the placebo group (P=0.013, relative risk [RR]=0.29, 95% confidence interval: 0.09-0.87). Penile deviation was not reduced by ESWT (P=0.66) but worsened in 20/50 (40%) and 12/49 (24.5%) patients of the ESWT and placebo-group, respectively (P=0.133). Plaque size reduction was not different between the two groups (P=0.33). Additional, plaque size increased in five patients (10.9%) of the ESWT group only. An improvement in sexual function could not be verified (P=0.126, RR=0.46). Despite some potential benefit of ESWT in regard to pain reduction, it should be emphasized that pain usually resolves spontaneously with time. Given this and the fact that deviation may worsen with ESWT, this treatment cannot be recommended.
- Research Article
1
- 10.4103/iju.iju_22_23
- Jun 30, 2023
- Indian Journal of Urology
Efficacy of low-intensity extracorporeal shockwave therapy (LiESWT) in Peyronie's disease (PD) has not been studied in an Indian population. Here, we studied the effect of LiESWT in Indian PD patients. This prospective study was conducted on 25 patients who completed weekly sessions of LiESWT for 6 weeks with a follow-up of 6 months. Patients were evaluated using International Index of Erectile Function (IIEF)-5 questionnaire for erectile dysfunction and visual analog scale for pain. Baseline and follow-up examinations included measurement of plaque size and curvature. The primary outcome was to assess remission of pain and reduction of plaque size along with improvement of penile curvature and erectile function as the secondary outcome. Primary goal of pain reduction and ≥50% reduction of plaque size was achieved in 64% and 20% of patients, respectively. Improvement in vaginal penetration during sexual intercourse and IIEF-5 score increase of ≥3 was achieved 20% and 36% cases, respectively. The mean reduction of penile curvature was more with plaque calcification (PC), but the difference was not statistically significant (P = 0.26). The difference in mean visual analog scale reduction was more in noncalcified plaque (P = 0.002). The mean reduction of plaque size in patients with PC was significant (P = 0.03). Shockwave therapy is a probable alternative treatment option. A significant improvement was observed in pain and plaque size in patients treated by LiESWT. The presence of PC may affect the outcome of LiESWT in PD.
- Research Article
32
- 10.1111/j.1745-7262.2006.00138.x
- May 1, 2006
- Asian Journal of Andrology
To determine retrospectively the safety and efficacy of extracorporeal shock wave therapy (ESWT) in patients with Peyronie's disease. Fifty-three patients with stable Peyronie's disease underwent ESWT (group 1). Fifteen patients matched with the baseline characteristic of the patients in group 1, who received no treatment, were used as the control (group 2). The patients' erectile function (International Index of Erectile Function [IIEF-5] score), pain severity (visual analog scale), plaque size and degree of penile angulation were assessed before and after the treatment in group 1 and during the follow-up in group 2. The mean follow-up time was 32 months (range: 6-64 months) in group 1 and 35 months (range: 9-48 months) in group 2. All the patients were available for the follow-up. Considering erectile function and plaque size, no significant changes (P > 0.05) were observed in group 1 before or after the ESWT. A total of 39 patients (74%) reported a significant effect in pain relief in group 1 after ESWT. However, regarding improvement in pain, IIEF-5 score and plaque size, no significant differences were observed between the two groups. In 21 patients (40%) of group 1, the deviation angle was decreased more than 10 degrees with a mean reduction in all patients of 11 degrees (range: 6-20 degrees). No serious complications were noted considering ESWT procedure. ESWT is a minimally invasive and safe alternative procedure for the treatment of Peyronie's disease. However, the effect of ESWT on penile pain, sexual function and plaque size remains questionable.
- Research Article
- 10.63360/ipmm.v1.e15
- Oct 9, 2025
- Invasive Physiotherapy and Musculoskeletal Medicine
Background and Objectives: Greater Trochanteric Pain Syndrome (GTPS) is a common condition characterized by chronic lateral hip pain, particularly among females aged 40 to 60. Various non-surgical options, corticosteroid injections (CSI), platelet-rich plasma (PRP) injections, and extracorporeal shockwave therapy (ESWT), are used, but their comparative effectiveness remains uncertain. This systematic review aimed to evaluate the effectiveness of ESWT compared to PRP and CSI in managing GTPS. Methods: A systematic literature search was conducted in March 2025 across PubMed, OVID Medline, and Embase, following PRISMA guidelines. Randomized controlled trials (RCTs) evaluating ESWT, PRP and CSI for GTPS were included. A total of 16 RCTs met the criteria: 6 on ESWT, 6 on PRP, and 4 on CSI. Methodological quality was assessed using the PEDro scale and Cochrane Risk of Bias Tool. Visual Analogue Scale (VAS) scores were extracted to compare pain outcomes at baseline, 3, 6, and 12 months. The most used tools for function and quality of life were the Harris Hip Score (HHS) and the Modified Harris Hip Score (mHHS). Results: All three treatments ESWT, PRP, and CSI showed reductions in pain and improvements in function and quality of life, as measured by VAS and other functional scores. 1,275 patients were grouped across 16 RCTs, enhancing consistency and comparability. ESWT showed the greatest pain relief at 3 months (VAS 3.14), compared to PRP (3.39) and CSI (3.78). At 12 months, ESWT and CSI had similar outcomes (VAS 3.71), while PRP had a higher score (4.52). However, variability in treatment protocols and baseline characteristics across study populations limits direct comparison and generalizability. Discussion and Conclusion: ESWT appears to offer rapid and sustained pain relief and functional benefit in GTPS. CSI offers similar long-term benefits, while PRP shows moderate mid-term promises. GRADE assessment indicates that the overall evidence is of moderate certainty in supporting all three non-surgical interventions for pain reduction in GTPS. However, further high-quality research is warranted.
- Research Article
45
- 10.1038/sj.ijir.3901192
- Feb 19, 2004
- International Journal of Impotence Research
To evaluate whether extracorporeal shockwave therapy (ESWT) offers an effective treatment for the main complications of Peyronie's disease (PD), that is, penile deformity and angulation, painful erection and most importantly unsatisfied sexual intercourse. From September 1999 to January 2001, 52 patients with PD were treated with ESWT. Pain during erection was assessed with a visual analogue scale. Penile deviation was determined by photographs with a goniometer. Five treatment sessions were performed at weekly intervals. Each consisted of 3000 shockwaves with an emission frequency of 120 shockwaves/min and a mean intensity of 0.17 mJ/mm(2). A Storz Minilith SL 1 with integrated inline ultrasound probe was used. In all, 52 patients were evaluated 6 weeks after ESWT for early follow-up. Before ESWT intercourse was difficult or impossible for 40 men; 29 patients suffered mainly from penile deformity, 14 from painful erection and eight mainly from loss of distal rigidity. A total of 30 patients mentioned painful erection before treatment. In 28 patients (93%) pain reduction was achieved. A total relief of pain was observed in 19 patients (63%). Mean pain score dropped from 4.2 to 1.3 in patients who suffered predominantly from painful erections. Intercourse satisfaction improved in 11 patients after therapy. Mean angulation before (40 degrees ) and after (37 degrees ) ESWT did not change significantly. Late follow-up after 11.1 months (4-17 months) could be completed in 36 patients. In total, 19 men reported that ESWT improved their PD. Of these, 16 noted no change. Only one of the patients noticed a worsening of his disease during or after treatment. Complication rate was low with only minor side effects such as minimal skin bruising; one urethral bleeding occurred. ESWT did reduce pain during erection in patients suffering mainly from painful erection due to PD. However, penile angulation did not improve significantly in our setup and thus intercourse difficulties did improve only in 28% of the patients. Therefore, we do not recommend ESWT as a primary treatment for PD.
- Research Article
44
- 10.1016/j.sxmr.2020.01.006
- Jun 2, 2020
- Sexual Medicine Reviews
Although the literature of the positive effects of penile low intensity extracorporeal shockwave therapy is meanwhile substantial, there are substantial differences regarding both the sources of energies and extracorporeal shockwave therapy (ESWT) devices. To provide an overview on the energy range and energy differences of the 6 currently marketed ESWT devices along with personal ESWT experiences in 350 patients. This review includes all published preclinical and clinical penile ESWT studies with evaluation of the technical differences of the 6 ESWT devices and the personal experiences with these 6 devices in ED and PD. The main outcomes measures were success rates in ED (International Index of Erectile Function-erectile function change, conversion of phosphodiesterase type 5 inhibitors non-responders) and PD (change in deviation and plaque size), differences of used sources of energy, and energy flux densities (EFDs). 3 different sources of energies are used, that is electromagnetic, electrohydraulic, and piezoelectric .The devices markedly distinguish in the available spectrum of the EFD ranging between 0.09 and 0.55 mJ/mm². In terms of the biological effects, the relevant energy parameters are-6 dB and the 5 MPa focus, which differ substantially between the ESWT devices. In addition, a great variability in the treatment protocols and applied energy is obvious. The preliminary own experiences with low intensity extracorporeal shockwave therapy in 160 ED non-responders and 190 patients with PD with success rates of 45% and 47%, respectively, are reported. Positive results were published with all 6 ESWT devices in question in patients with organic ED but with huge differences regarding the EFD and the total energies applied. There is growing evidence that concentrated treatment protocols and increasing energies may yield better results. In this context, it may be argued that at least some of the published studies were markedly underpowered .Owing to the paucity of published studies, the literature of the effects of ESWT in PD and for penile rehabilitation after pelvic surgery is currently not conclusive. Porst H. Review of the Current Status of Low Intensity Extracorporeal Shockwave Therapy (Li-ESWT) in Erectile Dysfunction (ED), Peyronie's Disease (PD), and Sexual Rehabilitation After Radical Prostatectomy With Special Focus on Technical Aspects of the Different Marketed ESWT Devices Including Personal Experiences in 350 Patients. Sex Med 2021;9:93-122.
- Research Article
9
- 10.1016/j.urology.2023.01.061
- Apr 17, 2023
- Urology
Stem-Cell, Shockwave, and Platelet Rich Plasma Therapy for the Treatment of Erectile Dysfunction and Peyronie’s Disease: A Survey of Clinics Across the USA
- Research Article
14
- 10.1111/andr.13240
- Aug 17, 2022
- Andrology
IntroductionExtracorporeal shock wave therapy is an established treatment for erectile dysfunction and Peyronie's disease. Concerns regarding the safety of extracorporeal shock wave therapy for andrological purposes on testicular function were raised by animal studies.AimTo evaluate the impact of extracorporeal shock wave therapy for erectile dysfunction or Peyronie's disease on reproductive and hormonal testicular function.MethodsWe designed a prospective controlled study in which consecutive patients were enrolled. Males aged between 18 and 40 years with mild vasculogenic erectile dysfunction or acute inflammatory Peyronie's disease and normozoospermia were included. All enrolled patients were offered extracorporeal shock wave therapy, and subjects who refused extracorporeal shock wave therapy for any reason were considered as the Control group. All patients in the Intervention group were treated with DUOLITH SD1 T‐TOP by a single expert urologist. Semen analysis and serum total testosterone dosage were performed before the start (T0) and 3 months after the end of extracorporeal shock wave therapy (T1) in Intervention group. The same parameters were evaluated after the extracorporeal shock wave therapy refusal (T0) and at the end of the following 3 months (T1) in Control group. Normozoospermia was chosen as the primary outcome, serum total testosterone concentration was selected as the secondary outcome.ResultsA total of 94 patients were enrolled in the study (48 Group A, 46 Group B). At T0, all patients were normozoospermic in both groups (p = 0.563), and no significant difference in mean ± SD total testosterone levels was recorded between the groups (582.5 ± 107.2 vs. 634.6 ± 108.4 ng/dl; p = 0.221). At T1, no significant deterioration (p > 0.05) in semen parameters was recorded in both groups. Only a statistically significant reduction in seminal pH was found after extracorporeal shock wave therapy compared to baseline (7.9 ± 0.3 vs. 7.5 ± 0.2; p < 0.001) and untreated patients (7.8 ± 0.2 vs. 7.5 ± 0.2; p < 0.001). No significant difference in total testosterone levels was recorded in Intervention group after extracorporeal shock wave therapy compared to baseline (p = 0.584).ConclusionExtracorporeal shock wave therapy in erectile dysfunction and Peyronie's disease patients does not seem to affect reproductive and hormonal testicular function.
- Abstract
1
- 10.1016/s0749-8063(03)00566-8
- Jul 1, 2003
- Arthroscopy: The Journal of Arthroscopic & Related Surgery
Paper #165 Sonographic evaluation of plantar fasciitis after
- Research Article
68
- 10.1007/s00345-016-1834-2
- Apr 23, 2016
- World journal of urology
The objective was to evaluate high-level evidence studies of extracorporeal shock wave therapy (ESWT) for urological disorders. We included randomized controlled trials reporting outcomes of ESWT in urology. Literature search on trials published in English using EMBASE, Medline and PubMed was carried out. The systematic review was performed according to PRISMA guidelines. We identified 10 trials on 3 urological indications. Two of 3 trials on Peyronie's disease (PD) involving 238 patients reported improvement in pain; however, no clinical significant changes in penile deviation and plaque size were observed. Four studies on erectile dysfunction (ED) including 337 participants were included. Using International Index of Erectile Function (IIEF-EF) and erectile hardness scale (EHS) data suggested a significant positive effect of ESWT in phosphodiesterase-5 inhibitor (PDE-5i) responders in 2 of 4 trials and 3 of 4 trials, respectively. Three studies on chronic pelvic pain (CPP) engaging 200 men reported positive changes in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). There was considerable heterogeneity between trials both with regard to treatment techniques and outcome measures, making it difficult to compare results. ESWT may resolve pain in PD patients, while evidence for reducing curvature and plaques size is poor. Effects of ESWT on IIEF in ED patients are inconsistent; however, data on EHS does imply that the treatment potentially may recover natural erection in PDE-5i responders. ESWT seems to be able to resolve pain in CPP patients in the short term. In all three disease entities, long-term outcome data are still warranted.
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