Guizhong Li et al., 2024: Low-intensity extracorporeal shock wave therapy for Peyroniès disease: a systematic review and meta-analysis

Guizhong Li 1, Xiao Xu 2, Libo Man 2
BMC Urol. 2024 Oct 8;24(1):217. doi: 10.1186/s12894-024-01607-4. PMID: 39375617
PMCID: PMC11459888 FREE TEXT

Abstract

Background: A systematic review of the evidence was conducted to assess the efficacy of low-intensity extracorporeal shock wave therapy (LI-ESWT) for patients with Peyronie`s Disease (PD).

Methods: A comprehensive search of the Cochrane Registry, PubMed and Embase databases was conducted to identify all controlled trials, including randomised controlled trials (RCTs), cohort studies and case-control studies, focusing on the efficacy of LI-ESWT in treating PD, and published before February 2023. The size of plaques, curvature deviation, visual analog scale [VAS] and International Index of Erectile Function (IIEF) were the most commonly used tool to evaluate the treatment effectiveness of LI-ESWT.

Results: There were 7 studies including 475 patients from 1999 to 2023. The meta-analysis of the data revealed that LI-ESWT could considerably enhance the proportion of men experiencing a reduction in penile plaques (RD 0.27, 95% CI: 0.04-0.50, P = 0.02), improvement in penile curvature (RD: 0.13; 95% CI, 0-0.26; p = 0.05), alleviation of pain (RD 0.22, 95% CI: 0.01-0.42, P = 0.04), and complete remission (RD 0.38, 95% CI 0.23-0.52, P < 0.00001). However, there were no significant differences in improvement of sexual function (MD: 1.44; 95% CI, -3.10-5.97; p = 0.53) between LI-ESWT and the placebo group.

Conclusions: According to these studies, LI-ESWT has the potential to decrease plaque size and improve penile curvature or pain in men with PD. The publication of robust evidence from additional well-designed long-term multicenter randomized controlled trials would provide more confidence regarding use of these devices in patients with PD.

Comment Jens Rassweiler 

Introduction Peyronie’s disease (PD) is a common condition in men characterized by the progressive fibrosis of the tunica albuginea, leading to symptoms such as:
• Penile pain
• Curvature of the penis
• Palpable plaques
• Erectile dysfunction (ED)
The incidence of PD ranges from 22.4 to 25.7 per 100,000 men, predominantly affecting those aged 50-59. Current treatment options primarily include conservative methods, with Collagenase Clostridium histolyticum (CCH) being FDA-approved. Alternative local treatments have shown limited evidence. Low-intensity extracorporeal shock wave therapy (LI-ESWT) has emerged as a treatment option, although results regarding its effectiveness in improving curvature and pain are mixed.
________________________________________The study aimed to evaluate the effectiveness of LI-ESWT in managing Peyronie’s disease through a systematic review and meta-analysis of existing literature.
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Methodology: Seven studies involving 475 patients were analyzed. These included:
o 2 case-control studies
o 1 cohort study
o 4 randomized controlled trials (RCTs)
Included men with a symptom history ranging from 3 to 12 months, particularly those for whom drug treatments had failed.

Treatment Protocols: Various devices were used, with treatment protocols differing in energy flux density (EFD) and session duration. Most studies used EFDs ranging from 0.25 to 0.29 mJ/mm².
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Findings: The following study results were summarized in the review.
1. Reduction of Penile Plaques:
o Three studies reported a significant increase in the proportion of patients with reduced plaque size after LI-ESWT (Risk Difference (RD) 0.27, 95% CI: 0.04–0.50, P=0.02).
o However, when measuring the actual plaque size reduction, there was no significant improvement compared to control groups.

2. Improvement of Penile Curvature:
o The analysis indicated a significant percentage of patients experienced improvement in penile curvature after LI-ESWT (RD: 0.13, P=0.05), but the actual angle of curvature showed no significant change (Mean Difference (MD): -2.14, P=0.4).
3. Pain Relief:
o The LI-ESWT group demonstrated a higher rate of pain relief (RD 0.22, P=0.04) and complete remission of pain (RD 0.38, P kleiner 0.00001) compared to control groups.
4. Sexual Function Improvement:
o There was no significant improvement in sexual function as measured by the International Index of Erectile Function (IIEF) scores (MD: 1.44, P=0.53) or in overall sexual function between LI-ESWT and control groups.
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Discussion The systematic review highlighted the potential benefits of LI-ESWT in reducing pain and improving the percentage of men with lessening penile plaques. However, the exact mechanisms by which LI-ESWT operates remain unclear. Proposed mechanisms include:
• Cell proliferation and tissue regeneration
• Enhanced blood flow and tissue perfusion
• Reduction of inflammatory cytokines

Several limitations were identified:
• Heterogeneity: Significant variability in study designs, patient demographics, and treatment protocols contributed to high levels of heterogeneity (I²=55-79%).
• Sample Size: Most studies had small sample sizes, with the largest including only 102 patients.
• Short Follow-Up Periods: Follow-ups were generally limited to about six months, raising questions about the long-term effectiveness of LI-ESWT.
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Conclusions: While LI-ESWT shows potential for improving symptoms associated with Peyronie’s disease, further high-quality, long-term, multicenter randomized controlled trials are necessary to establish its efficacy conclusively. Future research should focus on standardized outcome measures and a better understanding of the treatment mechanisms to optimize patient management strategies for PD. Unfortunately, this review does not offer new significant information. Moreover, recently published studies providing long-term results of ESWT with different energy settings. They also did not discuss the use of Li-ESWT in the management of the acute phase of PD.