Skip to main content

Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT)

Low-intensity extracorporeal shockwave therapy is a versatile, noninvasive modality with applications across multiple urologic and urogynecologic conditions. Evidence varies substantially by indication — from investigational (ED per AUA 2018) to effective for pain (CP/CPPS, Peyronie's pain) to early-stage / preclinical (female SUI, OAB, female sexual dysfunction).[1][2]

Cross-links: Erectile Dysfunction Decision Framework; Peyronie's Disease; PDE5 Inhibitors; IC/BPS; Chronic Pelvic Pain.

Mechanism of Action​

Li-ESWT uses energy flux densities < 0.25 mJ/mm² delivered via two physical forces — direct mechanical stress from the high peak pressure wave and cavitation bubble formation/collapse causing local microtrauma that triggers regenerative cascades:[3][4]

  • Neovascularization — VEGF, eNOS, and VEGF-receptor sensitization promote new blood vessel formation
  • Tissue regeneration — chemoattractant recruitment / activation of stem/progenitor cells; increased PCNA expression
  • Anti-inflammatory effects — downregulation of COX-2, IL-6, and NGF; modulation of inflammatory cascades
  • Nerve repair — increased neurotrophic factors, Schwann-cell activation
  • Increased tissue permeability — may facilitate intravesical drug delivery

1. Erectile Dysfunction​

Guideline positions​

  • AUA 2018 — Conditional Recommendation, Grade C; investigational: "findings from randomized sham-controlled trials do not clearly indicate that benefits reliably outweigh risks/burdens."[5]
  • EAU — may be used in mild organic ED or poor PDE5i responders; weak strength of recommendation.[6]
  • ESSM 2019 — efficacy "doubtful and deserves more investigation."[7]

Cochrane 2025 (21 RCTs, 1,357 men)[1]​

OutcomeEffectCertainty
Short-term IIEFMD 3.89 (95% CI 2.89–4.89; I² = 62%; 15 studies)Low
Long-term IIEFMD 5.25 (95% CI 2.47–8.04; I² = 87%; 5 studies)Low
Short-term EHSMD 1.06 (95% CI 0.83–1.28)Low
AEs vs shamRD 0.00 (I² = 0%)—
Discontinuation vs shamRR 0.77 (I² = 0%)—

Critical caveat (You 2026 meta of 19 RCTs): despite statistically significant pooled IIEF improvements at 1, 3, and 6 mo, the majority of studies failed to achieve the MCID — clinical meaningfulness is unclear.[8]

Best responders​

Mild-to-moderate ED outperforms severe ED / significant comorbidity.[9][10] Kalyvianakis 2022 double-blind RCT in moderate ED (n = 70) — 79% achieved MCID at 3 mo vs 0% sham (p < 0.0001).[11] PDE5i-refractory severe-ED diabetics show minimal improvement.[12]

Treatment parameters​

Substantial heterogeneity. Meta-regression suggests lower energy density (~0.09 mJ/mm²) and higher pulse number (≥ 3,000/session) are associated with better outcomes; typical protocols use 6–12 sessions, 1–2×/week, 1,500–5,000 pulses/session.[8][10]

Post-prostatectomy ED​

Excluded as a distinct population from Cochrane 2025.[1] A meta of 5 studies (n = 460) showed short-term IIEF benefit at 3–4 mo (WMD −2.04, p = 0.02) but no significant difference at 9–12 mo.[13] The most rigorous sham-controlled RCT (Pedersen 2025, n = 75) found no significant improvement in IIEF or EHS at 24 wk — median IIEF was 4 in both groups.[14] Jang 2023 (non-randomized) suggested early Li-ESWT + tadalafil superior to tadalafil alone for EHS ≥ 3 (OR 3.62, p = 0.041).[15]

2. Peyronie's Disease — pain only​

Strongest indication for Li-ESWT in PD is pain. AUA does not recommend it for curvature/plaque reduction. ESSM: "patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression."[7]

Sokolakis 2022 — largest sham-controlled RCT (n = 102, 3-yr follow-up)[16]​

  • Pain improvement at 4 wk: 16/34 vs 7/29 (p = 0.005); VAS MD 2.2 points (p = 0.002)
  • Pain improvement at 3 yr: 15/34 vs 7/29 (p = 0.031); VAS MD 2.5 points (p = 0.002)
  • No significant difference in curvature or sexual function at any time point
  • No treatment-related complications

Cochrane 2023 PD (3 studies, 151 participants)​

Li-ESWT may improve penile pain (MD −1.09; 95% CI −2.22 to 0.04; low certainty), but the CI crosses the MCID threshold.[17]

Spirito 2024 (n = 194 acute PD; 10-yr retrospective)[18]​

Persistent pain relief (VAS 6.5 → 3.1 at 3 mo → 1.0 at 12 mo, stable long-term), but curvature worsened (18.3° → 28.6° at 12 mo); satisfaction > 90%.

Bakr 2021 meta (3 RCTs, n = 238)​

No significant reduction in penile deviation, EF, or pain in pooled analysis. ESWT was associated with plaque-size reduction (OR 2.59, p = 0.02), of questionable clinical significance.[19]

Bottom line. Effective for pain (short- and long-term); no curvature, plaque, or EF benefit in controlled studies. Most useful in the acute / painful phase as an adjunct.

3. Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)​

The most consistently positive indication.

SourceFinding
Mykoniatis 2021 meta of 5 sham RCTs[20]NIH-CPSI pain WMD 3.2 (post-tx) → 4.4 (1 mo) → 3.61 (3 mo); total + QoL also improved; long-term LUTS / EF effects clinically insignificant
Wu 2026 meta of 8 RCTs (n = 455)[21]NIH-CPSI WMD −8.46; focused devices consistent (I² = 0%); radial devices extreme heterogeneity (I² = 98.2%)
Zheng 2026 SR of 11 studies[22]All demonstrated significant NIH-CPSI total + pain improvement; minor AEs (1 first-degree burn, 4 transient hematuria/hematospermia)
Labetov 2024 meta[23]Effect long-lasting through 6-mo follow-up (p < 0.05)
Cochrane 2018 (Franco)[24]High-quality evidence: ESWT reduced symptoms vs control at 12 wk (MD −6.18; 95% CI −7.46 to −4.89; I² = 34%)

Protocol comparison. Mykoniatis 2021 RCT of once-weekly vs twice-weekly (6 sessions, 5,000 pulses, 0.096 mJ/mm²) — no significant difference; both equally effective and safe.[25]

ESSM: "LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain."[7]

4. Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)​

Early but promising; not in the AUA IC/BPS guideline.[26]

  • Chuang 2020 double-blind placebo-controlled RCT (n = 54)[27] — primary endpoint (OSS) not met (both arms improved); however, significantly more ESWT patients achieved VAS ≥ 3 improvement at 4 wk (p = 0.035) and 12 wk (57.1% vs 19.0%, p = 0.011).
  • Shen 2021 RCT (n = 25)[28] — significant OSS / VAS reduction at 4 wk (p < 0.05).
  • Jhang 2023 prospective (n = 30)[29] — ICSI 12.87 → 7.87 sustained to 1 yr.
  • Preclinical (rat cystitis models) — Li-ESWT suppressed bladder overactivity, reduced COX-2/IL-6/NGF, improved inflammation.[30][31]

5. Female Stress Urinary Incontinence​

Investigational — no sham-controlled RCTs.

  • Long 2020 single-arm multicenter (n = 50 women) — 8 wk Li-ESWT improved pad-test leakage, Qmax, functional bladder capacity, frequency, urgency, and nocturia at 1-mo follow-up.[32]
  • Zhang 2020 irreversible rat SUI model[33] — increased leak-point pressure, increased urethral / vaginal smooth + striated muscle, restored urothelial integrity, increased progenitor cells.
  • Zambon 2019 narrative review — promising minimally invasive approach based on animal data; no controlled human trials.[34]

6. Overactive Bladder​

Investigational — no sham-controlled RCTs.

  • Lee 2020 prospective pilot (n = 82 women) — 8 wk Li-ESWT improved OAB questionnaires, functional bladder capacity, daytime frequency, urgency, nocturia, Qmax; sustained at 3-mo.[35]
  • Kimura 2022 ischemic OAB rat model — restored voiding intervals (14.9 vs 5.1 min), increased bladder blood flow, upregulated sGC-cGMP pathway with VEGF / CD31 induction.[36]

7. Vulvodynia / Provoked Vestibulodynia​

Strongest controlled evidence among female applications — two positive sham-controlled RCTs, though small.

  • Gruenwald 2021 double-blind sham-controlled RCT (n = 32 provoked vestibulodynia; 500 pulses, 0.09 mJ/mm², 2×/wk × 6 wk)[37] — dyspareunia VAS 8.0 → 4.4 at 3 mo (p < 0.001).
  • Hurt 2020 double-blind sham-controlled RCT (n = 62 vulvodynia; 3,000 pulses, 0.25 mJ/mm², weekly × 4)[38] — significant VAS and cotton-swab reductions at 1, 4, and 12 wk (p < 0.05).
  • Siegal & Chubak 2021 cautioned: "enthusiasm with which energy-based treatments for sexual dysfunction have been adopted is disproportionate to the amount of data currently available."[39]

8. Premature Ejaculation — experimental​

No dedicated sham-controlled RCTs of Li-ESWT monotherapy. A SR found dapoxetine + non-pharmacologic therapies (including shockwave) significantly improved IELT vs dapoxetine alone (SDM 1.6, p = 0.01).[40][41]

Comprehensive summary​

IndicationEvidenceKey findingGuideline
ED21 RCTs (Cochrane 2025); low certaintyIIEF +3.89 short-term; MCID uncertainAUA: investigational; EAU: weak
PD pain4 RCTs; low certaintyPain relief durable to 3 yr; no curvature benefitESSM: pain only
CP/CPPS5–8 sham RCTs; moderate–high certaintyNIH-CPSI improved; effects ≥ 3 moESSM: option for pain; Cochrane: high-quality
IC/BPS2 RCTs; low certaintyVAS ≥ 3 improvement; primary OSS not metNot in AUA IC/BPS
Female SUINo RCTs; preclinical + pilotAnimal tissue regeneration; uncontrolled humanInvestigational
OABNo RCTs; pilotSymptom and Qmax improvementInvestigational
Vulvodynia / vestibulodynia2 sham RCTs (small)Significant pain + sexual function improvementEmerging
Premature ejaculationNo dedicated RCTsAdjunct to dapoxetineExperimental

Safety profile (all indications)[1][16][22]​

  • Most common: minor bruising / ecchymosis, transient discomfort
  • Rare: hematuria, hematospermia (CP/CPPS), one reported first-degree burn
  • No serious AEs reported in any RCT across any indication
  • No difference vs sham in Cochrane ED review (RD 0.00)
  • No long-term safety concerns identified

Key unresolved issues​

  1. Protocol heterogeneity — energy density, pulse number, frequency, sessions, focused vs radial vs multifocal devices vary widely; the single greatest barrier to definitive conclusions.[8][21]
  2. Statistical vs clinical significance — many ED studies show statistically significant changes that fall below MCID.[8]
  3. Durability — long-term data > 6–12 mo sparse outside PD pain (3 yr) and CP/CPPS (6 mo).[16][23]
  4. Device type matters — focused devices show consistent CP/CPPS effects (I² = 0%) while radial devices show extreme heterogeneity (I² = 98.2%); head-to-head data lacking.[21]

Bottom Line for the Reconstructive Urologist​

Li-ESWT is investigational for ED with statistically significant but clinically uncertain benefit and no MCID-meeting majority across trials.[1][8] It is acceptable for pain in acute-phase Peyronie's (durable to 3 yr) but does not modify curvature.[16][18] It is the most consistently positive in CP/CPPS, where focused devices and ≥ 6 sessions deliver durable NIH-CPSI improvement.[20][21][24] It is emerging for IC/BPS and vulvodynia/vestibulodynia (small but positive sham-controlled data).[27][37][38] Female SUI and OAB applications are preclinical / pilot only. Counsel patients on heterogeneous protocols, uncertain durability, and out-of-pocket cost.

See Also​

References​

1. Ergun O, Kim K, Kim MH, et al. "Low-intensity shockwave therapy for erectile dysfunction." Cochrane Database Syst Rev. 2025;7:CD013166. doi:10.1002/14651858.CD013166.pub3

2. Ergun O, Kim K, Kim MH, et al. "Low-intensity shockwave therapy for erectile dysfunction: an abridged Cochrane review." BJU Int. 2026. doi:10.1111/bju.70236

3. Liu T, Shindel AW, Lin G, Lue TF. "Cellular signaling pathways modulated by low-intensity extracorporeal shock wave therapy." Int J Impot Res. 2019;31(3):170–176. doi:10.1038/s41443-019-0113-3

4. Wang HJ, Cheng JH, Chuang YC. "Potential applications of low-energy shock waves in functional urology." Int J Urol. 2017;24(8):573–581. doi:10.1111/iju.13403

5. Burnett AL, Nehra A, Breau RH, et al. "Erectile dysfunction: AUA guideline." J Urol. 2018;200(3):633–641. doi:10.1016/j.juro.2018.05.004

6. Schoofs E, Fode M, Capogrosso P, Albersen M. "Current guideline recommendations and analysis of evidence quality on low-intensity shockwave therapy for erectile dysfunction." Int J Impot Res. 2019;31(3):209–217. doi:10.1038/s41443-019-0132-0

7. Capogrosso P, Frey A, Jensen CFS, et al. "Low-intensity shock wave therapy in sexual medicine — clinical recommendations from the European Society of Sexual Medicine (ESSM)." J Sex Med. 2019;16(10):1490–1505. doi:10.1016/j.jsxm.2019.07.016

8. You CH, Kang YN, Wen YC, et al. "A close look at the evidence on low-intensity shockwave therapy in erectile dysfunction — a systematic review and meta-analysis of RCTs." J Sex Med. 2026;23(4):qdag070. doi:10.1093/jsxmed/qdag070

9. Lu Z, Lin G, Reed-Maldonado A, et al. "Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis." Eur Urol. 2017;71(2):223–233. doi:10.1016/j.eururo.2016.05.050

10. Man L, Li G. "Low-intensity extracorporeal shock wave therapy for erectile dysfunction: a systematic review and meta-analysis." Urology. 2018;119:97–103. doi:10.1016/j.urology.2017.09.011

11. Kalyvianakis D, Mykoniatis I, Pyrgidis N, et al. "The effect of low-intensity shock wave therapy on moderate erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial." J Urol. 2022;208(2):388–395. doi:10.1097/JU.0000000000002684

12. Bayraktar N. "Non-invasive alternative for phosphodiesterase inhibitor-refractory erectile dysfunction: real-life experience with low-intensity extracorporeal shockwave therapy." Medicine. 2023;102(45):e35939. doi:10.1097/MD.0000000000035939

13. Rho BY, Kim SH, Ryu JK, et al. "Efficacy of low-intensity extracorporeal shock wave treatment in erectile dysfunction following radical prostatectomy: a systematic review and meta-analysis." J Clin Med. 2022;11(10):2775. doi:10.3390/jcm11102775

14. Pedersen TB, Secher C, Moumneh A, et al. "A prospective randomized study on low-energy extracorporeal shock wave therapy for erectile dysfunction after radical prostatectomy." J Urol. 2025;214(2):156–166. doi:10.1097/JU.0000000000004576

15. Jang SW, Lee EH, Chun SY, et al. "Comparison of the efficacy of the early LI-SWT plus daily tadalafil with daily tadalafil only as penile rehabilitation for postprostatectomy erectile dysfunction." Int J Impot Res. 2023;35(5):447–453. doi:10.1038/s41443-022-00560-w

16. Sokolakis I, Pyrgidis N, Lahme S, Hatzichristodoulou G. "Low-intensity shockwave therapy in Peyronie's disease: long-term results from a prospective, randomized, sham-controlled trial." Int J Impot Res. 2022;34(5):487–494. doi:10.1038/s41443-021-00447-2

17. Rosenberg JE, Ergun O, Hwang EC, et al. "Non-surgical therapies for Peyronie's disease." Cochrane Database Syst Rev. 2023;7:CD012206. doi:10.1002/14651858.CD012206.pub2

18. Spirito L, Manfredi C, La Rocca R, et al. "Long-term outcomes of extracorporeal shock wave therapy for acute Peyronie's disease: a 10-year retrospective analysis." Int J Impot Res. 2024;36(2):135–139. doi:10.1038/s41443-023-00673-w

19. Bakr AM, El-Sakka AI. "Extracorporeal shockwave therapy in Peyronie's disease: systematic review and meta-analysis." J Sex Med. 2021;18(10):1705–1714. doi:10.1016/j.jsxm.2021.06.012

20. Mykoniatis I, Pyrgidis N, Sokolakis I, et al. "Low-intensity shockwave therapy for the management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and meta-analysis." BJU Int. 2021;128(2):144–152. doi:10.1111/bju.15335

21. Wu MJ, Kao CC, Yang MH, Tsao CW, Chen CL. "Optimizing the use of extracorporeal shock wave therapy for CP/CPPS: a modality-based systematic review and meta-analysis comparing focused and radial devices." J Clin Med. 2026;15(3):1270. doi:10.3390/jcm15031270

22. Zheng Y, Dundee P, Manohar P, Sneddon S, Anderson P. "Safety and efficacy of extracorporeal shock wave therapy for the management of chronic pelvic pain syndrome: a systematic review." Urology. 2026;209:136–143. doi:10.1016/j.urology.2026.01.015

23. Labetov I, Vaganova A, Kovalev G, Shkarupa D. "Extracorporeal shockwave therapy in treatment of chronic prostatitis/chronic pelvic pain syndrome: systematic review and meta-analyses." Neurourol Urodyn. 2024;43(8):1924–1937. doi:10.1002/nau.25524

24. Franco JV, Turk T, Jung JH, et al. "Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome." Cochrane Database Syst Rev. 2018;5:CD012551. doi:10.1002/14651858.CD012551.pub3

25. Mykoniatis I, Pyrgidis N, Kalyvianakis D, et al. "Comparing two different low-intensity shockwave therapy frequency protocols for nonbacterial chronic prostatitis/chronic pelvic pain syndrome: a two-arm, parallel-group RCT." Prostate. 2021;81(9):499–507. doi:10.1002/pros.24119

26. Clemens JQ, Erickson DR, Varela NP, Lai HH. "Diagnosis and treatment of interstitial cystitis/bladder pain syndrome." J Urol. 2022;208(1):34–42. doi:10.1097/JU.0000000000002756

27. Chuang YC, Meng E, Chancellor M, Kuo HC. "Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome — a prospective, multicenter, randomized, double-blind, placebo-controlled study." Neurourol Urodyn. 2020;39(5):1505–1514. doi:10.1002/nau.24382

28. Shen YC, Tyagi P, Lee WC, Chancellor M, Chuang YC. "Improves symptoms and urinary biomarkers in refractory interstitial cystitis/bladder pain syndrome patients randomized to extracorporeal shock wave therapy versus placebo." Sci Rep. 2021;11(1):7558. doi:10.1038/s41598-021-87040-1

29. Jhang LS, Hsieh WC, Huang TX, et al. "Use of low-intensity extracorporeal shock wave therapy in the management of interstitial cystitis/bladder pain syndrome patients: a thirty-case study." Neurourol Urodyn. 2023;42(1):65–72. doi:10.1002/nau.25027

30. Wang HJ, Lee WC, Tyagi P, Huang CC, Chuang YC. "Effects of low-energy shock wave therapy on inflammatory molecules, bladder pain, and bladder function in a rat cystitis model." Neurourol Urodyn. 2017;36(6):1440–1447. doi:10.1002/nau.23141

31. Chen YL, Lin YP, Sun CK, et al. "Extracorporeal shockwave against inflammation mediated by GPR120 receptor in cyclophosphamide-induced rat cystitis model." Mol Med. 2018;24(1):60. doi:10.1186/s10020-018-0062-1

32. Long CY, Lin KL, Lee YC, et al. "Therapeutic effects of low-intensity extracorporeal low-energy shock wave therapy (LiESWT) on stress urinary incontinence." Sci Rep. 2020;10(1):5818. doi:10.1038/s41598-020-62471-4

33. Zhang X, Ruan Y, Wu AK, et al. "Delayed treatment with low-intensity extracorporeal shock wave therapy in an irreversible rat model of stress urinary incontinence." Urology. 2020;141:187.e1–187.e7. doi:10.1016/j.urology.2020.03.035

34. Zambon JP, Williams KJ, Bennington J, Badlani GH. "Applicability of regenerative medicine and tissue engineering for the treatment of stress urinary incontinence in female patients." Neurourol Urodyn. 2019;38 Suppl 4:S76–S83. doi:10.1002/nau.24033

35. Lee YC, Chuang SM, Lin KL, et al. "Low-intensity extracorporeal shock wave therapy ameliorates the overactive bladder: a prospective pilot study." BioMed Res Int. 2020;2020:9175676. doi:10.1155/2020/9175676

36. Kimura S, Kawamorita N, Kikuchi Y, et al. "Low-energy shock wave therapy ameliorates ischemic-induced overactive bladder in a rat model." Sci Rep. 2022;12(1):21960. doi:10.1038/s41598-022-26292-x

37. Gruenwald I, Gutzeit O, Petruseva A, Gartman I, Lowenstein L. "Low-intensity shockwave for treatment of vestibulodynia: a randomized controlled therapy trial." J Sex Med. 2021;18(2):347–352. doi:10.1016/j.jsxm.2020.11.006

38. Hurt K, Zahalka F, Halaska M, Rakovicova I, Krajcova A. "Extracorporeal shock wave therapy for treatment of vulvodynia: a prospective, randomized, double-blind, placebo-controlled study." Eur J Phys Rehabil Med. 2020;56(2):169–174. doi:10.23736/S1973-9087.20.05903-1

39. Siegal A, Chubak BM. "Pharmaceutical and energy-based management of sexual problems in women." Urol Clin North Am. 2021;48(4):473–486. doi:10.1016/j.ucl.2021.06.006

40. Chang J, Zhao W, Ma L, et al. "Management of male premature ejaculation: from past to future." Front Endocrinol. 2025;16:1718109. doi:10.3389/fendo.2025.1718109

41. Nieves Martín M, Marín Novoa P, Avendaño-Coy J. "Dapoxetine combined with non-pharmacological approaches for lifelong premature ejaculation. A systematic review and meta-analysis." J Sex Med. 2025:qdaf238. doi:10.1093/jsxmed/qdaf238