Radiofrequency and shock waves in Peyronie's disease: systematic review and preliminary results of a pilot study

Lenzi J1, Mamede C1, Almeida R1, Araújo E1, Lemos A1, Brasil C1, Jorge D1, Sodré D1, Quibervile A1, Sodré P1, Gomes T1, Cerqueira M1, Cantharino C1, Marianno A1, Teles A1, Balthazar C1, Araújo R1, Canário A1, Pereira I1, Santos J1, Oliveira M1, Rezende L2, Freire P1, Lordêlo P1

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 120
On Demand Conservative Management
Scientific Open Discussion Session 14
On-Demand
Sexual Dysfunction Pain, other Male
1. Patrícia Lordêlo´s Institute (IPL) - Pelvic Floor Care Center (CAAP) - Bahiana School of Medicine and Public Health, 2. UNIFAE
Presenter
J

Juliana Lenzi

Links

Abstract

Hypothesis / aims of study
Peyronie's disease (PD) is characterized by the presence of fibrotic plaques in the tunica albuginea, compromising the penis size with effects on sexual function like pain and the penetration incapacity. The most effective treatment so far is the plaque removal through a surgical procedure, however post-surgical impotency rate ranges from 60 to 80%. The searches for non-surgical treatment procedures with low cost and risk are constant. Shock Waves (SW) is an acoustic wave which carries high energy and low frequency, but its effectiveness on PD treatment is still controversial. Radiofrequency (RF) is a diathermy technique with action on the collagen and elastin molecules, relieving the tissue. Therefore, since the publication of a systematic review, there is the hypothesis of the association of both techniques.
Aim of the study: Verify the results of the Shockwaves usage on PD treatment through a systematic review and describe the effect of Shockwaves Plus Radiofrequency (SW + RF) on patients with Peyronie's disease.
Study design, materials and methods
We conducted a systematic review according to Performed Preferred Reporting Items for Systematic Reviews and Meta-analyzes (PRISMA)1. The search was carried out in electronic databases: PubMed and EMBASE and it used both Medical Subject Headings (MeSH), as well as Boolean operators "AND" and "OR". The keywords were: Peyronie’s Disease; Shockwave Therapy; Erectile Dysfunction. The inclusion criteria were studies published until December 2020, that evaluated the outcome of curvature of the penis.
The search was carried out by two authors independently and after selecting the inclusion criteria, the findings were compared. When there was a discrepancy, a third appraiser was consulted, and this was resolved by consensus.
The pilot study was conducted with 10 patients with PD symptoms that were forwarded to a reference center in Salvador-BA. The diagnosis was confirmed by a radiologist that performed ultrasonographic images of the plaque after the erection induction through the application of 0,5 ml of Qaudrimix R9 of FLUKKA PHARMA, containing prostaglandin, papaverine, phentolamine and atropine. The USG exam was responsible for the penis study, through the ventral face scan, evaluated in the transversal and in the longitudinal, from the glans to the base of the penis, searching for hyperechoic focal thickening of the tunica albuginea and evaluating its dimensions. Still with the erection induction, it was performed a photographic documentation to measure the penis angulation with the patient in orthostasis. It was investigated the capacity of penetration and classified in: 1 = absent, 2 = present and painful, 3 = present and not painful.
The RF + SW technique was performed by physiotherapists using IBRAMED’s devices like Thork model (SW) and Neartek model (RF) having the respective parameters: 120 mj, 10 Hz and 2000 pulses, with 15 mm stainless steels radial electrode and 38ºC (100,4ºF), monopolar and with 20 mm resistive electrode. Before it was performed, the plaque was palpated to identify the application spot.
At the end of the treatment, the evaluation protocol was repeated, and the patient was questioned about the treatment satisfaction on a scale of 0 to 10. The higher the number the greater the satisfaction.
Results
We founded 205 articles. After the analysis 13 publications were included in this review.
Hauck et al. showed the average plaque size in the ESWT group increased after treatment but decreased in the control group. This result corroborates with Hatzichristodoulou et al. who demonstrated assigned 102 men with stable Peyronie's disease for at least 3 months to 6 ESWT sessions with 2,000 shockwave shots per session. Palmieri et al showed that, with the four weekly treatment sections, the average plaque size and average degree of curvature remained unchanged in the ESWT group. In a report of 25 cases, Claro et al showed an improvement in curvature. However, there was no comparison with the control group and ESWT was associated with another therapy.
So far, there have been five patients with an average age of 56,3 years with Peyronie’s disease diagnosed for at least one year. The results of the measurement plaque in the ultrasound, angulation through photography, satisfaction and penetration capacity are on table 1. No adverse effects were reported by the five participants.
Interpretation of results
ESWT is a non-invasive therapy, safe to apply in clinical practice and has been used in different disorders in urology. We conducted an extensive literature search and the compiled data of 654 patients on the use of ESWT in relation to Peyronie's disease demonstrates that there is no clear biological theory for the effects of OCD and does not point to benefits in relation to curvature.
For these reasons, it seems reasonable to test the application associated to another technique. There was a reduction in the plaque length measures and in the angulation through the photographic documentation. However, it is important to say that the plaque thickness and/or the histological tissue evaluation better represent the changes through the treatment of SW + RF.
The satisfaction with the treatment was related to the penetration capacity, but as the satisfaction was not maximum, it is supposed that the penis apparency influence aesthetics, decreasing satisfaction.  
Besides, another hypothesis is related to the technique parameters, like application frequency and number of sections. In this systematic review was not found the pattern of these variables.
Concluding message
The results of our systematic review revealed that the ESWT doesn't seem to be an effective choice for PD patients when related to the curvature outcome. That said, more high-quality studies are necessary to overcome the limitations of the current data. For now, in the pilot study, there were no reports of adverse effects. Besides, there was a change in all patient satisfaction, in the USG measure, in the angulation measure and in the penetration capacity, in the majority the SW+RF appears to be a promising therapeutic option for PD, requiring more randomize clinical trials.
Figure 1 Evaluation before and after using objective and subjective criteria for evaluating the responses of 5 participants submitted to the application of the shockwave plus radiofrequency technique.
Figure 2
References
  1. Palmieri A, Imbimbo C, Longo N, Fusco F, Verze P, Mangiapia F, Creta M, Mirone V. A first prospective, randomized, double-blind, placebo-controlled clinical trial evaluating extracorporeal shock wave therapy for the treatment of Peyronie's disease. Eur Urol. 2009 Aug;56(2):363-9. doi: 10.1016/j.eururo.2009.05.012. Epub 2009 May 18. Erratum in: Eur Urol. 2009 Nov;56(5):e43-4. PMID: 19473751.
  2. Di Mauro M, Russo GI, Della Camera PA, Di Maida F, Cito G, Mondaini N, Capece M, Falcone M, Sessa F, Mari A, Campi R, Sabini C, Serni S, Gacci M, Minervini A, Carini M, Cimino S, Morelli G, Cocci A. Extracorporeal Shock Wave Therapy in Peyronie's Disease: Clinical Efficacy and Safety from a Single-Arm Observational Study. World J Mens Health. 2019 Sep;37(3):339-346. doi: 10.5534/wjmh.180100. Epub 2019 Mar 26. PMID: 30929330; PMCID: PMC6704308.
  3. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71.
Disclosures
Funding Ibramed Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee Bahiana School of Medicine and Public Health Helsinki Yes Informed Consent Yes
17/04/2024 08:30:32