Fathi A. et al., 2026: Low-intensity shock wave therapy for penile rehabilitation in patients with erectile dysfunction following pelvic fracture urethral injury: a pilot study.

Fathi A, Alsagheer G, Talaat M, AbdelRazek M.
Int Urol Nephrol. 2026 Jun 23. doi: 10.1007/s11255-026-05246-6. Epub ahead of print.

Abstract

Purpose: Pelvic fracture urethral injury (PFUI) frequently results in long-term erectile dysfunction (ED), severely impacting quality of life. Low-intensity shockwave therapy (LiSWT) promotes neovascularization and tissue perfusion via VEGF and nitric oxide pathways, offering a potential regenerative treatment for post-traumatic ED. This study aims to evaluate the efficacy and safety of LiSWT for ED secondary to urethral injury from pelvic fractures.

Methods: This pilot study included 25 men with ED post-PFUI. Participants received six weekly sessions of LiSWT (24,000 shocks total) using a piezoelectric device. Assessments included the International Index of Erectile Function (IIEF) and Erectile Hardness Scale (EHS) at baseline and at 3, 6, and 12 months' post-treatment, while penile Doppler ultrasound was done at baseline and 12 months' post-treatment.

Results: IIEF scores improved significantly from 14.4 ± 3.2 at baseline to 17.4 ± 3.2 (p = 0.002) post-LiSWT, 16.4 ± 3.2 (p = 0.036) at 3 months, 17.4 ± 3.2 (p = 0.002) at 6 months, and 17.8 ± 3.7 (p < 0.001) at 12 months. EHS increased significantly at all follow-ups (p < 0.001), with a further rise between 3 months 2.35 ± 0.53 and 12 months 2.74 ± 0.58 (p = 0.009). PSV increased from 23.4 ± 6.1 at baseline to 34.1 ± 9.1 (p < 0.001) at 12 months, EDV decreased from 6.68 ± 2.95 at baseline to 3.84 ± 2.70 (p = 0.002) at 12 months, and RI increased from 0.66 ± 0.22 at baseline to 0.86 ± 0.13 (p < 0.001) at 12 months.

Conclusion: LiSWT is safe and effective for ED after PFUI, producing sustained improvements in erectile function, penile rigidity, and hemodynamics, representing a promising noninvasive therapeutic option for post-traumatic ED.

Comment Jens Rassweiler

This pilot study evaluated low-intensity shock wave therapy (LiSWT) as penile rehabilitation for men with erectile dysfunction (ED) after pelvic fracture urethral injury (PFUI) and subsequent urethroplasty.

Material and Methods

Patients: 25 adult men with ED after PFUI and successful urethroplasty were tretaed with six weekly LiSWT sessions using a piezoelectric device ELvation® ­ Piezowave2 linear focused piezoelectric device (Richard Wolf, Knittlingen, Germany). 4000 shocks/session with an energy density of 0.16 mJ/mm² were applied on corpora cavernosa and penile crura.

Follow-up included IIEF and EHS at baseline, post-treatment, 3, 6, and 12 months; penile Doppler at baseline and 12 months.

Results

Mean IIEF score improved from 14.4 ± 3.2 at baseline to 17.8 ± 3.7 at 12 months. Mean EHS score improved from 1.58 ± 0.37 at baseline to 2.74 ± 0.58 at 12 months suggesting better penile rigidity after LiSWT, with continued improvement over time. Accordingly, the authors report that by 12 months:

• 20% achieved normal erectile function
• 40% had mild ED
• 36% had mild-to-moderate ED

Penile Doppler showed favorable vascular changes:

• PSV increased from 23.4 ± 6.1 to 34.1 ± 9.1 cm/s
→ suggesting improved arterial inflow.
• EDV decreased from 6.68 ± 2.95 to 3.84 ± 2.70 cm/s
→ suggesting improved venous competence.
• RI increased from 0.66 ± 0.22 to 0.86 ± 0.13
→ suggesting improved veno-occlusive function.

No adverse events were reported, including

Discussion

Strengths of the paper include

- a clinically relevant population since ED after pelvic fracture urethral injury is difficult to treat and has major quality-of-life implications, especially because many affected patients are young or middle-aged men.

- the study included both questionnaire-based outcomes, such as IIEF and EHS, and objective Doppler parameters with a longer follow-up than many pilot studies: A 12-month follow-up is useful because LiSWT is proposed to have regenerative rather than purely symptomatic effects.

- a clear treatment protocolThe shock wave dose, frequency, target areas, and device type were described.

Important limitations of the article

1. Small sample size: Only 25 patients completed the study. This limits statistical power and makes it difficult to generalize the findings. However, fortunately there are not so many patients at a trauma canter with such problems.

2. No control or sham group: This is the biggest limitation. Without a sham-control group, it is not possible to determine how much of the improvement was due to:.

3. Retrospective trial registration: The trial was registered in 2026, while the study period was July 2023 to December 2024. Retrospective registration weakens transparency and raises concerns about prespecified outcomes.

4. No comparison with standard ED therapies: The study prohibited PDE5 inhibitors and injections during follow-up, which helps isolate the LiSWT effect, but it also means the study does not show whether LiSWT is better than, equal to, or complementary to standard ED therapies.

Conclusion

This study suggests that LiSWT may improve erectile function after PFUI-associated ED, including both patient-reported function and penile vascular parameters. The improvement in PSV, EDV, and RI is especially interesting because post-traumatic ED may involve arterial injury, venous leakage, neurogenic damage, or mixed mechanisms.

However, because this was a small uncontrolled pilot study, the findings should be considered hypothesis-generating, not definitive. LiSWT appears promising, but it cannot yet be considered established therapy for this specific patient group based on this study alone.

.Jens Rassweiler