What standardized shockwave therapy protocols have been tested for Peyronie’s disease and what were their results?
Executive summary
Extracorporeal shockwave therapy (ESWT) for Peyronie’s disease has been tested in two broad, standardized incarnations—high‑energy lithotripsy protocols and low‑intensity extracorporeal shockwave therapy (Li-ESWT or LiST)—with most controlled trials and meta-analyses agreeing that shockwave shortens penile pain and may shrink plaques but does not reliably improve curvature or long‑term sexual function [1] [2] [3].
1. What "standardized" protocols have been used: high‑energy lithotripters versus low‑intensity regimens
Clinical series and comparative reports separate into high‑energy ESWT delivered with electromagnetic lithotripters (devices historically used for kidney stones) and low‑intensity shockwave schedules designed for tissue modulation; retrospective cohorts describe high‑energy regimens under local anesthesia with sonographic/fluoroscopic targeting using devices like Siemens Lithostar/Lithoskop [4], while randomized and sham‑controlled trials most often tested low‑intensity schedules of multiple sessions (commonly six sessions) that became the de facto standardized LiST protocol in trials [5] [6].
2. What outcomes these protocols measured and the consistent findings
Trials and meta‑analyses consistently measured penile pain (VAS), plaque size, curvature degrees, and erectile function scores (IIEF), and found the clearest, most reproducible benefit for pain resolution and sometimes plaque shrinkage, with limited or no effect on curvature or meaningful erectile function improvement in pooled results [7] [2] [1] [3].
3. Results from randomized, sham‑controlled trials and long‑term follow‑ups
Placebo‑controlled randomized studies (including the 2013 J Sex Med trial and a 102‑patient randomized sham‑controlled LiST trial) showed pain reduction faster than natural history and at least short‑term superiority for LiST on pain, with the larger randomized LiST trial reporting durable pain benefit on long‑term follow‑up but no convincing curvature or sexual‑function gain versus sham [8] [5].
4. What meta‑analyses and systematic reviews conclude about efficacy
Systematic reviews and meta‑analyses paint a cautious picture: updated meta‑analyses conclude ESWT is safe and can reduce plaque size and relieve pain but cannot be recommended as a proven treatment for curvature or sexual function—some reviews even report failure to improve curvature or pain when pooled across heterogeneous RCTs—highlighting inconsistent endpoints, variable devices and energies, and non‑standardized reporting as central limitations [1] [3] [9].
5. Heterogeneity in protocols explains much of the controversy
The conflicting literature is driven by marked heterogeneity: studies differ in energy flux density, total shock counts, session number and spacing, device type (electrohydraulic, electromagnetic, piezoelectric), patient selection (acute versus chronic disease, plaque calcification, curvature complexity) and outcome metrics; authors of reviews explicitly call for multi‑institutional randomized trials with standardized methods and strict inclusion criteria to resolve whether any protocol alters anatomy versus symptomatic course [7] [10] [1].
6. Practical interpretation and where evidence is strongest
For clinicians and patients the evidence supports Li‑ESWT or ESWT as a safe, minimally invasive option when the therapeutic goal is rapid pain control or modest plaque reduction—especially in early or active disease—but not as a substitute for evidence‑based interventions directed at correcting curvature (surgery, intralesional collagenase for selected patients); international systematic reviews and long‑term RCT follow‑ups emphasize safety but stop short of endorsing ESWT as a curvature‑modifying standard of care [5] [11] [1].