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Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT)

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a noninvasive modality studied in several urologic and urogynecologic conditions. Evidence varies substantially by indication. The AUA 2018 guideline calls it investigational for ED.[5] Trials report pain benefit in CP/CPPS and in Peyronie's disease, although the Peyronie's evidence is inconsistent. Applications in female SUI, OAB and female sexual dysfunction are early-stage or preclinical.[1][2]

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

Mechanism of Action​

Treatment energy varies by device and indication; cited trials used 0.096 mJ/mm² in CP/CPPS and up to 0.25 mJ/mm² in IC/BPS.[25][28] Preclinical studies propose that it acts through two physical forces: direct mechanical stress from the high peak pressure wave, and cavitation bubble formation or collapse that causes local microtrauma and is thought to trigger regenerative cascades.[3][4] The proposed effects are:

  • Neovascularization. VEGF, eNOS, and VEGF-receptor sensitization promote new blood vessel formation
  • Tissue regeneration. Chemoattractant recruitment or activation of stem or 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

Focused versus radial devices. Most ED efficacy trials used focused shockwave devices (piezoelectric, electromagnetic or electrohydraulic sources derived from lithotripsy technology), which concentrate energy at a defined focal depth. The CP/CPPS evidence below includes both focused and radial devices.[21][42] Radial wave devices generate a pressure wave by a ballistic projectile striking an endplate; the wave disperses radially from the applicator with rapid energy attenuation rather than converging on a focal point, producing lower peak energy and a less-defined treatment zone. Radial devices are less stringently regulated than the focused devices studied in ED trials and are often marketed directly to patients. The same focused-versus-radial distinction affects reported outcomes in CP/CPPS below.[7]

1. Erectile Dysfunction​

Guideline positions​

  • AUA 2018. Conditional Recommendation, Grade C: low-intensity ESWT should be considered investigational for men with ED because randomized sham-controlled trials did not clearly show that benefits outweigh risks and burdens.[5]
  • EAU 2026. Use Li-SWT, with or without PDE5 inhibitors, in men with mild vasculogenic ED, as an alternative in well-informed men who do not want or are not suitable for oral therapy, and in vasculogenic ED with poor PDE5i response .[42] An earlier review of guideline recommendations reached a similar conclusion.[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
IIEF-EF at >3 monthsMD 5.25 (95% CI 2.47–8.04; I² = 87%; 5 studies, 276 men)Low
Short-term EHSMD 1.06 (95% CI 0.83–1.28)Low
AEs vs shamRD 0.00 (95% CI -0.01 to 0.02; I² = 0%)Low
Discontinuation vs shamRR 0.77 (95% CI 0.47–1.27; I² = 0%)Low

The Cochrane authors note that the short-term IIEF-EF difference may not reach the 4-point MCID, and that all included trials had treatment periods of 3 months or less.[1] A 2026 meta-analysis of 19 RCTs (You) found statistically significant pooled IIEF improvements at 1, 3 and 6 months, but most studies failed to reach the MCID, so clinical benefit remains unclear.[8]

Best responders​

In a 2017 meta-analysis, men with mild-to-moderate ED had better responses than men with more severe ED or comorbidities.[9] A 2022 double-blind, sham-controlled RCT in moderate ED (n = 70) reported that 27 of 34 evaluated men (79%) reached the MCID at 3 months versus none in the sham group (p < 0.001).[11] In a retrospective series of 126 PDE5i-refractory men, the severe-ED group, which had a higher prevalence of diabetes, showed no significant improvement.[12]

Treatment parameters​

Protocols are heterogeneous. A 2018 meta-analysis of 9 RCTs found larger IIEF gains with lower energy density (0.09 mJ/mm²), 3,000 pulses per treatment and courses shorter than 6 weeks.[10] The 2026 meta-regression associated treatment frequency and pulse number per course with response and could not identify a superior regimen.[8] The sham-controlled trial above used 12 sessions twice weekly, 5,000 impulses, 0.096 mJ/mm² and 5 Hz.[11]

Post-prostatectomy ED​

The Cochrane 2025 review excluded men after radical prostatectomy.[1] A review of five studies (460 men after radical prostatectomy or cystoprostatectomy) found a small IIEF advantage at 3–4 months in the three RCTs with analyzable IIEF data (n = 200; WMD −2.04, 95% CI −3.72 to −0.35; I² = 73%; low certainty). Its two-study 9–12-month analysis, which also included observational evidence, showed no statistically significant difference (WMD −5.37, 95% CI −12.42 to 1.69; I² = 99%).[13] A sham-controlled RCT (Pedersen 2025, n = 75) found no significant improvement in IIEF or EHS at 24 weeks, with a median IIEF of 4 in both groups.[14] A prospective comparative study of 80 completers (Jang 2023) reported that early Li-ESWT plus daily tadalafil was more often associated with EHS ≥ 3 at 6 months than tadalafil alone (OR 3.62, p = 0.041).[15]

2. Peyronie's Disease — pain only​

The strongest signal for Li-ESWT in Peyronie's disease is for pain. The EAU 2026 guideline weakly recommends ESWT for acute-phase penile pain and strongly recommends against its use to improve curvature; it also reports no plaque-size benefit.[42] The AUA 2015 guideline says clinicians may offer ESWT to improve penile pain but should not use it to reduce curvature or plaque size .[48] ESSM: "patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression."[7]

Sokolakis 2022, sham-controlled RCT in stable PD (n = 102 randomized; 63 evaluated at 3 years)[16]​

  • Pain improvement at 4 wk: 16/34 versus 7/29 (p = 0.005); VAS MD 2.2 points (p = 0.002)[16]
  • Pain improvement at 3 yr: 15/34 versus 7/29 (p = 0.031); VAS MD 2.5 points (p = 0.002)[16]
  • 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; I² = 59%; low certainty), but the CI crosses the one-point MCID threshold.[17] The review rated the effect on curvature as little to no difference.[17]

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

Mean follow-up was 125.6 months. Pain fell from 6.5 to 3.1 at 3 months and 1.0 at 12 months and stayed stable. Mean curvature worsened from 18.3° to 28.6° at 12 months and then stabilized. Satisfaction was > 90%.[18] There was no control group.

Bakr 2021 meta (3 RCTs, n = 238)​

The pooled analysis found no significant reduction in penile deviation and no effect on erectile function or pain scale. ESWT was associated with plaque-size reduction (OR 2.59, p = 0.02), of questionable clinical significance.[19]

Bottom line. A sham-controlled RCT found greater pain improvement at 3 years among 63 of 102 randomized men who returned for assessment; an uncontrolled acute-PD series also reported prolonged pain reduction. Pooled pain estimates remain inconsistent: Bakr 2021 found no effect, and Cochrane 2023 reported a low-certainty estimate whose confidence interval included no effect.[16][18][19][17] Controlled studies show no curvature or erectile function benefit. Li-ESWT is used as an adjunct in the acute, painful phase.

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

The AUA 2025 male chronic pelvic pain guideline advises discussing low-intensity ESWT with patients who have CP/CPPS .[43] This recommendation concerns CP/CPPS; the AUA's investigational classification for ED applies to a different indication.[5][43]

Results are most consistently positive in this 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]At follow-up closest to 12 wk, NIH-CPSI WMD −8.46 (I² = 94.8%); exploratory device subgroups: focused WMD −6.59 (I² = 0%); radial imprecise, extreme heterogeneity (I² = 98.2%)
Zheng 2026 SR of 11 studies[22]All reported significant NIH-CPSI total and pain improvement versus baseline and/or control; minor AEs (one first-degree burn and four cases of transient hematuria or hematospermia)
Labetov 2024 meta[23]Effect long-lasting through 6-mo follow-up (p < 0.05)
Cochrane 2018 (Franco)[24]Short-term NIH-CPSI MD −6.18 (95% CI −7.46 to −4.89; 3 studies, 157 participants; high certainty); may not be sustained at medium-term follow-up (low certainty)

Protocol comparison. In a 50-man RCT of six sessions at 5,000 pulses and 0.096 mJ/mm², once- and twice-weekly schedules did not differ significantly in symptoms or treatment-related pain at 1 or 3 months; neither arm had reported adverse events.[25]

ESSM 2019: "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; not in the AUA IC/BPS guideline.[26]

  • Chuang 2020 double-blind placebo-controlled RCT (54 screened; 49 randomized, 24 ESWT and 25 placebo)[27]: primary endpoint (OSS) not met (both arms improved); however, more ESWT patients achieved VAS ≥ 3 improvement at 4 wk post-treatment (p = 0.035) and at 12 wk post-treatment among 21 evaluated per arm (12/21 [57.1%] versus 4/21 [19.0%], p = 0.011).
  • Shen 2021 planned single-center biomarker substudy of the Chuang trial (25 randomized; 24 analyzed: 13 ESWT, 11 placebo)[28]: between-group OSS and VAS improvements at 4 weeks post-treatment (p < 0.05).
  • Jhang 2023 prospective (n = 30)[29]: ICSI 12.87 to 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. A single-blind, sham-controlled RCT randomized 60 women with SUI or stress-predominant mixed urinary incontinence (45 active, 15 sham); four weeks of Li-ESWT reduced pad-test leakage versus sham.[45] Longer follow-up was principally within the active arm, so comparative durability remains uncertain.[45]

  • Long 2020 single-arm multicenter study (n = 50 women): Li-ESWT was combined with Kegel exercises. Pad-test leakage, functional bladder capacity, urgency and nocturia improved from baseline at one-month follow-up; daytime frequency improved at eight weeks, whereas Qmax did not significantly change.[32]
  • Zhang 2020 irreversible rat SUI model[33]: increased leak-point pressure, increased urethral or vaginal smooth and striated muscle, restored urothelial integrity, increased progenitor cells.
  • Zambon 2019 narrative review: minimally invasive approach based on animal data; no controlled human trials.[34]

6. Overactive Bladder​

Investigational. A single-blind, sham-controlled RCT randomized 65 women (50 active, 15 sham) to eight weekly treatments. The report describes symptom and diary improvement through six months, but longer-term outcomes were largely compared with baseline rather than sham.[46] In a separate RCT, 137 men with persistent storage symptoms after transurethral surgery for benign prostatic obstruction were randomized; at three months, OABSS fell 55% with Li-SWT versus 11% with sham (76 and 21 assessed, respectively).[50]

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

7. Vulvodynia / Provoked Vestibulodynia​

Two small sham-controlled RCTs are the strongest controlled evidence among the female applications.

  • Gruenwald 2021 double-blind sham-controlled RCT (n = 32 provoked vestibulodynia; 500 pulses, 0.09 mJ/mm², 2×/wk × 6 wk)[37]: dyspareunia VAS fell from 8.0 to 4.4 at 3 months (p < 0.005 versus baseline).
  • Hurt 2020 double-blind sham-controlled RCT (n = 62 vulvodynia; 3,000 pulses, 0.25 mJ/mm², weekly × 4)[38]: VAS and cotton-swab reductions at 1, 4 and 12 weeks in the treatment group (p < 0.01), with no significant change in the placebo group.
  • 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​

A four-arm randomized trial in 212 men with lifelong PE included Li-ESWT monotherapy and a control arm without sham shockwave treatment.[40][49] A systematic review pooled eight RCTs (656 men) of dapoxetine plus varied nonpharmacologic treatments versus dapoxetine alone; IELT favored combination therapy (standardized mean difference 1.6, 95% CI 0.5–2.8; p = 0.01).[41]

In a four-arm randomized trial of 212 men with lifelong PE, Li-ESWT alone (n = 50) showed a small fold-IELT increase (p = 0.04) but no statistically significant PEP (p = 0.12) or global-impression improvement (p = 0.15); the trial did not include a shockwave-sham arm.[49]

The AUA/SMSNA 2020 guideline advises counseling that evidence is insufficient to support alternative therapies for PE .[44]

Comprehensive summary​

IndicationEvidenceKey findingGuideline
ED21 RCTs (Cochrane 2025); low certainty[1]IIEF-EF mean difference +3.89 versus sham in 15 RCTs (937 men) at up to 3 mo; clinical importance uncertain[1]AUA 2018: investigational[5]; EAU 2026: Weak recommendation for selected vasculogenic ED[42]
PD painSham RCT plus pooled analyses; low certaintyAt 3 yr, pain improved in 15/34 LiST versus 7/29 sham patients among 63/102 randomized men who returned in one stable-PD RCT[16]; pooled pain estimate inconsistent[17]; no curvature benefit[16][42]EAU 2026: pain, acute phase ; ESSM: pain in acute or stable PD[42][7]
CP/CPPS5 sham RCTs in Mykoniatis 2021; 8 RCTs with sham or standard-therapy controls in Wu 2026[20][21]NIH-CPSI improved; effects through 3 mo in Mykoniatis sham RCTs[20]AUA 2025: discuss [43]; ESSM 2019: option for non-inflammatory CP/CPPS (NIH-IIIB)[7]; Cochrane 2018: high certainty for short-term NIH-CPSI improvement[24]
IC/BPSOne small multicenter sham-controlled RCT and an overlapping 24-person biomarker substudy; low certainty[27][28]Parent trial missed its primary OSS endpoint; a secondary pain-response signal favored ESWT[27]Not in AUA IC/BPS
Female SUISmall sham RCTs plus uncontrolled and preclinical studiesOne trial reported four-week pad-test improvement versus sham; the pooled sham comparison was not significant and comparative durability is uncertainInvestigational[32][33][47]
OABSmall sham RCTs with overlapping cohorts plus pilot studiesShort-term symptom improvement versus sham; Qmax gains and longer follow-up are largely within-armInvestigational[35][47]
Vulvodynia / vestibulodynia2 small sham RCTs[37][38]Pain measures improved in both active arms; sexual-function scores improved from baseline in the 32-woman vestibulodynia trial[37][38]Emerging
Premature ejaculationOne randomized Li-ESWT monotherapy arm without a shockwave sham[40][49]Shockwave-specific patient-reported benefit remains unestablished[40][41][49]Experimental

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

  • Most common: minor bruising / ecchymosis, transient discomfort
  • In the 11 CP/CPPS studies reviewed by Zheng, investigators reported one first-degree burn and four cases of transient hematuria or hematospermia.[22]
  • Serious adverse events were not reported in the sources reviewed here
  • No difference versus sham in Cochrane ED review (RD 0.00)
  • Long-term safety data are limited

Key unresolved issues​

  1. Protocol heterogeneity. Energy density, pulse number, frequency, sessions, and focused, radial or multifocal devices vary across studies, limiting comparisons and conclusions about a preferred regimen.[8][21]
  2. Statistical versus clinical significance. Many ED studies show statistically significant changes that fall below MCID.[8]
  3. Durability. Data beyond 6–12 months are sparse; one Peyronie's pain RCT evaluated 63 men at 3 years, while a CP/CPPS meta-analysis reported effects through 6 months.[16][23]
  4. Device subgroups. In exploratory CP/CPPS subgroup analyses at follow-up closest to 12 weeks, focused-device trials had I² = 0%, while radial-device trials had I² = 98.2%; head-to-head data are lacking.[21]

Bottom Line for the Reconstructive Urologist​

Li-ESWT is investigational for ED in the AUA guideline, with statistically significant but clinically uncertain benefit and most trials falling short of the MCID.[1][5][8] The EAU gives a weak recommendation for mild vasculogenic ED.[42] In acute-phase Peyronie's disease it is used for pain and does not change curvature.[16][18][42] Results are most consistently positive in CP/CPPS. In Wu 2026, an exploratory focused-device subgroup showed NIH-CPSI improvement with I² = 0% at follow-up closest to 12 weeks; separate reviews reported improvement at 3 and 6 months across study protocols.[20][21][23] One sham-controlled IC/BPS trial found a secondary pain-response signal despite missing its primary OSS endpoint; separate small sham-controlled trials reported improvement in vulvodynia or vestibulodynia.[27][37][38] Female SUI and OAB have small sham-controlled trials, but remain investigational. A review of non-prostatic urinary indications found heterogeneous protocols, short follow-up and uncertain clinical utility.[47] Patients are counseled about heterogeneous protocols, uncertain durability and out-of-pocket cost.

See Also​

References​

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