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Low intensity shock wave therapy in sexual medicine – clinical recommendations from the European Society of Sexual Medicine (ESSM)

Paolo Capogrosso
Università Vita-Salute San Raffaele
Milan, Italy
Unit of Urology; URI; IRCCS Ospedale
San Raffaele, Milan, Italy

Anders Frey
University of Southern Denmark
Department og Urology
Esbjerg and Odense, Denmark

Christian Fuglesang, S. Jensen
University of Copenhagen
Herlev and Gentofte Hospital
Department of Urology
Copenhagen, Denmark

Giulia Rastrelli
University of Florence
Andrology, Female Endocrinology and Gender Incongruence Unit
Department of Experimental, Clinical and Biomedical Sciences
Florence, Italy

Giorgio I.Russo
Urology section-University of Catania,
Catania, Italy

Josep Torremade 
Hospital Universitari de Bellvitge
Barcelona, Spain

In the last decade, low intensity shock-wave therapy (LISWT) has been tested as a physical treatment modality for several uro-andrological diseases including erectile dysfunction (ED), Peyronie’s Disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Preclinical animal model studies have shown that the molecular mechanisms of LISWT may be related to different pathways of biological reactions: besides triggering neovascularization via the upregulation of the vascular endothelial growth factor (VEGF) and its receptor[1]shock wave focusing, coupling, and application have appeared that may address some of these problems. OBJECTIVE: To present a consensus with respect to the physics and techniques used by urologists, physicists, and representatives of European lithotripter companies.

Evidence Acquisition

We reviewed recent literature (PubMed, Embase, Medline, LISWT has been found to promote progenitor cell activation, proliferation, migration and differentiation in penile tissue[2]. In vivo studies have demonstrated a differentiation of penile endogenous stem/progenitor cells toward smooth muscle cells and endothelial cells after localised LISWT treatment, resulting in a restoration of cavernosal tissue architecture in rat models of ED characterized by penile fibrosis and impaired vascularization[2]. In an animal model of cavernous nerve injury, LISWT was able to induce nerve regeneration by enhancing the recruitment and the activation of progenitor Schwann cells[3]. In the context of PD, it has been suggested that LISWT may exert a direct mechanical effect thus remodelling the penile plaque; moreover, the increase in local blood circulation could lead to the enhancement of inflammation and macrophage activity resulting in plaque lysis[4]. Finally, LISWT appeared to induce hyperstimulation of nociceptors, interrupting the flow of the nerve impulses responsible for pain in patients with CPPS[5] and may reduce the perineal muscle tone and spasticity when applied to the perineum[5]. However, all these findings deserve further investigation in order to come to any final conclusions.

Several randomized clinical trials (RCTs) and meta-analyses have investigated the role of LISWT for the treatment of ED, PD and CPPS, in humans but the clinical significance of this treatment method remains controversial. The European Society of Sexual Medicine (ESSM) has recently reviewed the evidence on LISWT for ED, PD and CP/CPPS and has proposed position statements for the use of LISWT in clinical practice, which are briefly summarized in this article.

Erectile Dysfunction

1. Treatment efficacy

1.1. Patient reported outcomes (IIEF, EHS)

Current evidence is promising but is still controversial, therefore a clear clinical recommendation of LISWT for ED cannot be made and more high quality studies are needed.

To date eleven RCTs have investigated the clinical effects of LISWT on erectile function (EF). Most of them have a low-risk of bias and have been conducted in a double-blind fashion, although the blinding methodology has rarely been described in detail. Among them, the study by Srini and colleagues [6] suffers from high risk of bias due to a drop-out rate of 37% in the treatment group and 58% in the placebo group, casting doubts on the reliability of their findings. Likewise, the multi-centre trial conducted by Motil and coworkers [7] suffers from a poor description of methodology which results in a high risk of bias. Seven of the remaining studies were sham-controlled trials [8–14] and were considered by the ESSM committee to assess treatment efficacy. Of them, three trials [8,11,13] reported statistically significant results in regards to IIEF-EF and EHS improvement, two trials showed no difference [10,12] while two studies [9,14] reported a significant improvement only for one of the investigated outcomes (e.g. EHS or IIEF-EF).

Among the trials showing a positive effect of LISWT on EF there is the first published RCT [8], which included a total of 60 patients. The mean change from baseline IIEF-EF score after 1 month of follow-up was 6.7 points in the treatment group (n = 40) and 3 points in the sham group (n = 20) (p = 0.03) while the rate of patients reporting an EHS 3-4 score (meaning an erection hard enough for penetration) was 78% in the treatment group compared to 35% in the sham group. Similar data were reported by Kitrey and co-workers [11] in terms of IIEF-EF and EHS improvements after 1 month from the end of treatment. Interestingly the authors reported that 40.5% of patients in the LISWT group showed a clinically meaningful EF improvement according to the minimum clinically important differences (MCID) criteria compared to none in the sham group. In a more recent double-blind trial, the authors performed repeated follow-up assessments, showing no significant difference in the change of the IIEF-EF score after 1 month of follow-up, while significant results favouring treatment were observed at 3, 6, 9 and 12 months. Similar findings were reported by Yamacake et al. investigating the effect of LISWT among kidney transplanted men with ED: they reported a 5-point increase of the IIEF-EF in 70% of patients in the treatment group vs. only 10% in the sham group [14].

On the other hand, negative findings regarding treatment efficacy have been reported by other authors: in their RCT, Yee et al. showed no difference in the IIEF-EF or EHS scores at 1 month follow-up, although the study did not reach the minimum number of patients required to reach significance according to a power calculation [10]. Likewise, Fojecki and co-workers showed no statistically significant changes in the IIEF-EF and EHS score both at short and long-term follow-up [12,15]. However, it should be noted that in this trial the authors applied a gel pad delivering the shockwaves at skin level, which could have led to sub-optimal treatment due to poor penetration of the energy into the tissues. Finally, controversial findings were published in a last trial [9] where difference was observed in the IIEF-EF domain score changes between the LISWT and the sham group, but the rate of EHS 3-4 was 57% vs. 9% in the treatment and sham group respectively (p = 0.0001).

Furthermore, five meta-analyses have investigated the effect of LISWT on ED showing an overall positive effect in terms of IIEF-EF score improvement, although the estimates are small (ranging from about 2 to 4 points of the IIEF-EF) and the heterogeneity among included studies is high [16–20]

1.2. Penile hemodynamics

LISWT significantly improves penile hemodynamic parameters of patients with vasculogenic ED. However, the clinical long-term significance of this improvement is uncertain (Level 2; Grade C).

Changes in penile hemodynamics, as assessed with penile Duplex ultrasound, have been reported only in 3 sham-controlled trials [8,11,13]. All of them showed a significant improvement in penile blood flow in the actively treated group as compared to controls.

1.3. Effect endurance

Current data suggest a variable effect of LISWT on EF up to 12 months after treatment (Level 2; Grade C). More data are needed to assess the longer-term effects of LISWT.

Overall, the above mentioned trials suffer from short follow-up, ranging from 1 to 12 months. In one non-sham controlled trial, Kalyvianakis and co-workers [21] randomized 42 patients to either 6 or 12 sessions of LISWT, with a repeated 6-session treatment course after 6 months: results suggested that repeating LISWT after 6 months could further improve the efficacy.

2. Treatment protocol

2.1 Energy source and type of SW (linear vs. focussed)

Currently, there are no studies comparing the two treatment methodologies. Further research should address the possible differences between focussed and linear SW.

Several types of SW generators have been used: most of the studies were performed with focussed SW generators and only 2 RCTs used a linear generator[7,12]. There are no data directly comparing the two types of generators; in one meta-analysis the authors performed a sub-group analysis according to the type of generators used, reporting a significant improvement of the IIEF-EF only for studies applying focussed SWs [18].

2.2. Settings and Protocol

There are only few data comparing different treatment protocols with the same SW generator, therefore a specific protocol cannot be suggested.

Treatment protocols vary widely among RCTs in terms of either energy flux density (EFD), number of SWs per session and length of treatment. There are no studies directly comparing different protocols.

3. Indication

LISWT for patients with vasculogenic ED, either treatment-naïve, responders or non-responders to PDE5-inhibitors, shows encouraging results, but unambiguous evidence for efficacy is lacking, pooled effect size is modest, and evidence quality is low. Patients should be informed about the conflicting results regarding efficacy of this treatment when discussing LISWT (Level 2; Grade D).

All RCTs included patients with vasculogenic ED with mild to severe levels of the disease. Data from meta-analyses showed controversial findings: Man et al. found a statistically significant EF improvement in patients with mild and severe ED[18]; moreover, patients who used PDE5is during treatment showed better results than those who did not. Lu et al.[17] reported a significant EF improvement only for patients with mild ED and for patients using PDE5is.

4. Safety

LISWT is a safe and well-tolerated procedure without clinically significant adverse events (Level 1; Grade A).

No adverse events (AEs) have been reported in sham-controlled trials.

Peyronie’s Disease

1. Treatment efficacy

1.1. Curvature:

Current data do not support the use of LISWT to reduce curvature (Level 2; Grade B).

Four RCTs were included in the analysis on the efficacy of ESWT in PD [22–25]. Of them, 3 were sham-controlled trials while one study compared LISWT with the combination of LISWT + tadalafil[25]. Mean curvature degree and plaque size were unchanged in 2 RCTs including only patients with stable disease [23,24]. In one trial including patients reporting a PD onset below 12 months, the authors observed a small decrease in curvature and plaque size in the LISWT group (-1.4º and -0.6 cm2, respectively) which was statistically significant [22]. The same group performed a further RCT comparing LISWT vs. LISWT plus tadalafil 5 mg once daily: no significant effect was observed in terms of curvature and plaque size in both groups.

Penile pain as assessed with the Visual Analogue Score (VAS) was significantly improved by LISWT in several trials [22,24].

Gao et al. performed a meta-analysis including RCTs, cohort studies and case-control studies [26]. Pooled data analysis showed a higher chance of observing a lessening of the plaque, relief of pain and complete remission of pain in the LISWT group compared to controls. However, insignificant differences were found in improvement of penile curvature and sexual function [40].

2. Treatment protocol

No recommendation can be given on energy source and protocol. Further studies are needed.

Concerning the energy delivered for PD treatment, there are no data comparing different treatment protocols and energy sources.

3. Indication

LISWT can be proposed as an option to reduce pain in patients with either acute or stable PD. (Level 2; Grade B)

Overall, two RCTs included patients with pain in the early acute phase of the disease [22,25], while in the other trials only patients with a stable PD were enrolled [23,24]. According to these data, the presence of pain should drive the indication for LISWT rather than the disease phase.

4. Safety

LISWT is a well-tolerated procedure without severe adverse events (Level 2; Grade B).

In 4 RCTs and 3 non-randomized, controlled studies [27–29]successfully used in orthopedic or salivary stones because of its lithotriptic power, can be used to break plaques in Peyronie’s disease.\nMETHODS: A total of 130 patients affected with Peyronie’s disease were entered into a prospective trial. Patients with completely calcified plaques as determined by ultrasound evaluation were excluded. We divided the patients into three treatment groups: (A LISWT was associated with petechiae along the wave direction on the penile surface (8.5%), skin haemorrhage (7%) and slight urethral bleeding (21%). No serious AEs were reported.

Chronic Pelvic Pain Syndrome

1. Treatment efficacy

1.1. Pain:

LISWT is an option to consider with the aim of improving prostatitis-like symptoms in patients with CP/CPPS. However, due to the limited evidence from clinical trials, and the off-label nature of this treatment, LISWT should not be considered the primary treatment for CP/CPPS (Level 2; Grade B).

Present knowledge on the efficacy and tolerability of LISWT in CP/CPPS treatment is based on 5 low-to-moderate quality studies, of these 4 are sham-controlled RCTs [30–33]setting, and participants: Sixty patients suffering from CPPS for at least 3 mo were investigated in two groups. Both groups were treated four times (once per week and 1 is a trial comparing LISWT to medical therapy with anti-inflammatory agents and alpha-blockers [34].

In CP/CPSS subjects, LISWT showed an improvement of prostatitis-like symptoms and pain observed after 12 weeks of follow-up [30–33]setting, and participants: Sixty patients suffering from CPPS for at least 3 mo were investigated in two groups. Both groups were treated four times (once per week. In particular, the decrease in NIH-CPSI total score was between 17 and 33% among the LISWT treated group and almost null or even increased in the sham-treated men [43-45]. However, these findings were not sustained after 24 weeks, as reported by the longest sham-procedure controlled trial [33]and the aim of this study was to evaluate the effect of extracorporeal shockwave therapy on CPPS due to non bacterial prostatitis in a long-term period.\\n\\nMATERIALS AND METHODS: In a follow-up survey, 40 patients with CPPS (that were randomly distributed into the treatment or sham groups were evaluated at 16, 20, and 24 weeks. In the treatment group, patients were treated by extracorporeal shock wave therapy (ESWT.

1.2. Other outcomes:

No specific recommendation could be made on the effects of LISWT in CP/CPPS men regarding non-symptomatic outcomes, i.e. objective measures of prostate health.

Current evidence on the effects of LISWT on prostate characteristics at imaging or urodynamic parameters is insufficient to draw meaningful conclusions.

2. Treatment protocol

No specific recommendation can be made about technical details including number of pulses, energy and frequency to be used.

Concerning the energy delivered for the LISWT, most trials use perineal application with 3000 pulses, maximum total energy flow density of 0.25 mJ/mm2 and a frequency of 3 Hz with a schedule of one application weekly for 4 weeks. All generators were used with focused SW. Unfortunately, there are no available data comparing different treatment protocols with the same SW generator, therefore a specific protocol cannot be suggested.

3. Indication

LISWT can be considered an option for patients with non-inflammatory CP/CPPS (NIH- IIIB).

All available RCTs have been conducted in patients with non-inflammatory CP/CPPS (category IIIB according to the National Institute of Health classification (NIH)).

4. Safety

LISWT as a therapy for CP/CPPS is not associated with any severe adverse events. LISWT is a safe and well-tolerated procedure (Level 2; Grade B).

No major adverse events were reported in all randomized trials assessing LISWT for CP/CPPS, thus suggesting that this is a safe and well-tolerated procedure.

Conclusions

In the last decade, great enthusiasm arose about the application of LISWT in sexual medicine. Evidence from pre-clinical studies along with the results of the first RCTs depicted LISWT as a promising therapy for ED. However, those encouraging results were not confirmed in further published trials. In such a case, meta-analyses could be a useful research methodology to provide an answer to a controversial clinical question. Pooled-data analyses have supported the effectiveness of LISWT in improving the EF of patients with vasculogenic ED; however, these findings should be interpreted with caution, given the bias associated with the included studies and the high heterogeneity in terms of patients’ baseline characteristics, treatment protocols and study design. Even more important, the reported treatment effect is rather small, casting doubts on the actual clinical significance of the observed improvement in psychometric scores.

The application of LISWT in the context of PDs has shown less enthusiastic results. Available data are consistent regarding a lack of efficacy in terms of plaque size reduction and improvement of curvature. However, patients experiencing pain in the acute phase of the disease may benefit from this treatment.

Finally, LISWT could be a feasible option for the improvement of symptoms in men with CP/CPPS. However, this positive effect has been observed in few trials with a limited follow-up. The modification of non-subjective parameters has not been adequately studied so far.

New treatment methods have to be assessed in terms of both risks and benefits. In the case of LISWT, the benefits are still controversial, while there is consistent evidence supporting the safety and tolerability of this treatment. As such, LISWT could be reasonably proposed as a treatment option in a research context after counseling the patient that its efficacy has not been definitively proven.

After approximately 10 years of intensive clinical research, several answers to important clinical questions are still missing: is LISWT an effective treatment? Is LISWT only effective for a few select patients? What is the best protocol to ensure a higher probability of treatment success? How long does the effect last? Futures studies are still needed to address these questions.

References

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