Low-intensity shockwave therapy and pelvic floor muscle training each mitigate erectile dysfunction in men with diabetes: a randomised controlled trial

Adding either Li-ESWT or home pelvic floor training to sildenafil improved penile blood flow in 90 diabetic men; shockwave led by 10 cm/sec

Journal: Journal of Physiotherapy | Published: 2026-04-02 | Type: Three-arm RCT | PMID: 41933953 Authors: Ahmad Mahdi, Abosteit Hassan, Said Ahmed, Ramy Salama (Egyptian physical therapy and andrology institutions, Al-Azhar University) Funding/COI: Not listed

Summary

This Egyptian RCT randomized 90 men with type 2 diabetes and arteriogenic ED into three groups — all receiving background sildenafil, with one group adding weekly Li-ESWT for 6 weeks, one adding home-based pelvic floor muscle training (PFMT), and one getting sildenafil only. Both active treatments outperformed sildenafil alone on penile blood flow (peak systolic velocity) and the IIEF-5. Li-ESWT outperformed PFMT on PSV by a mean of 10 cm/sec and on IIEF-5 by 1.4 points. Neither treatment was tested without sildenafil, so the isolated effect of either intervention remains unknown.

Claims

• Li-ESWT vs. PFMT: mean difference in cavernosal artery PSV (bilateral) of 10 cm/sec (95% CI 9–11)
• Li-ESWT vs. PFMT: mean difference in IIEF-5 of 1.4 points (95% CI 0.9–1.9)
• Both Li-ESWT and PFMT improved PSV and IIEF-5 versus sildenafil-only control (specific between-group vs. control values not reported in abstract)
• Li-ESWT protocol: 0.09 mJ/mm², six bilateral penile points, once weekly, 6 weeks
• PFMT: home-based, 6 weeks (protocol details not specified in abstract)
• Background sildenafil: 25 mg daily + 50 mg on demand across all three arms

Study Quality

This is a methodologically reasonable trial for its scope: concealed allocation, assessor blinding, and intention-to-treat analysis are all present — the minimum credible infrastructure for an RCT. Using objective vascular measurement (Doppler PSV of cavernosal arteries) alongside a patient-reported outcome (IIEF-5) adds credibility beyond self-report alone. Registering the trial (NCT06058832) before running it suggests pre-specified outcomes.

That said, n=90 (30 per arm) is modest. The 6-week follow-up window captures acute response only — there is no data on whether improvements persist, decay, or require maintenance. Blinding of participants was not possible (the treatments are physically distinct), which risks performance and expectation bias on the IIEF-5, a questionnaire sensitive to placebo effects. The 1.4-point IIEF-5 advantage for Li-ESWT over PFMT is statistically tight but falls short of the minimum clinically important difference commonly cited in the literature (approximately 2–5 points), raising questions about practical significance.

Red Flags

• Funding and COI not disclosed — for a paper testing a device-based intervention, this is a material transparency failure
• No sham control for Li-ESWT — men knew which active treatment they received; expectation effects on IIEF-5 cannot be ruled out
• Sildenafil background in all arms — the independent effect of either intervention without PDE5 inhibitor support is untested
• Six-week follow-up only — no durability data; ED in diabetic men is a chronic condition
• IIEF-5 advantage of 1.4 points: statistically significant, clinical significance contested
• PFMT protocol not detailed in abstract — adherence and technique verification for a home-based exercise program are unclear
• Single-center, single-country sample — generalizability to other populations and healthcare settings uncertain

Strengths

• Registered RCT (NCT06058832) with concealed allocation and ITT analysis
• Objective hemodynamic endpoint (Doppler PSV) alongside patient-reported IIEF-5
• Active comparator design — tests Li-ESWT against an established non-pharmacological intervention, not just placebo
• Assessor blinding preserved
• Homogeneous population (arteriogenic ED in T2DM) reduces confounding from mixed ED etiologies
• Clinically relevant question: both PFMT and Li-ESWT are accessible, relatively low-risk adjuncts to pharmacotherapy

Verdict

A solid-enough RCT design let down by a short follow-up, no sham control for the device arm, missing funding disclosure, and a primary IIEF-5 difference that is statistically real but clinically marginal. The finding that home pelvic floor training beats sildenafil alone is arguably the more actionable signal here — it's cheap, accessible, and shows a vascular improvement on Doppler. The Li-ESWT advantage is real by the numbers, but 1.4 IIEF-5 points over 6 weeks against a background of daily sildenafil does not make a compelling case on its own. Worth reading if you're tracking Li-ESWT in diabetic ED; not worth citing as definitive evidence of superiority.