Ahmad AM. et al., 2026: Low-intensity shockwave therapy and pelvic floor muscle training each mitigate erectile dysfunction in men with diabetes: a randomised controlled trial.

Ahmad AM, Abosteit EH, Said Kadah A, Draz RS.
J Physiother. 2026 Apr;72(2):122-127. doi: 10.1016/j.jphys.2026.03.009. Epub 2026 Apr 2.

Abstract

Question: What are the effects of low-intensity extracorporeal shockwave therapy (Li-ESWT) and of pelvic floor muscle training (PFMT) on penile blood flow and erectile function in men with type 2 diabetes mellitus and erectile dysfunction (ED)?

Design: Three-arm randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis.

Participants: Ninety subjects aged 35 to 55 years with type 2 diabetes mellitus and arteriogenic ED.

Interventions: All groups were on sildenafil treatment: 25 mg daily and 50 mg on demand. The Li-ESWT group received Li-ESWT with an energy flux intensity of 0.09 mJ/mm2 once per week for 6 weeks. The Li-ESWT was applied to six points bilaterally on the ventral aspect of the penile shaft (distal, middle and proximal) and the right and left penile crura. The PFMT group received home-based PFMT for 6 weeks. The control group received only the sildenafil treatment.

Outcome measures: The peak systolic velocity (PSV) of the right and left cavernosal arteries and the five-item version of the International Index of Erectile Function (IIEF-5, scored from 5 worst to 25 best) were assessed at baseline and after 6 weeks.

Results: Compared with control, Li-ESWT and PFMT each improved PSV of cavernosal arteries bilaterally and IIEF-5. Compared with PFMT, Li-ESWT improved PSV of cavernosal arteries bilaterally (difference in mean change 10 cm/sec, 95% CI 9 to 11) and IIEF-5 total score (difference in mean change 1.4, 95% CI 0.9 to 1.9).

Conclusion: Combined with sildenafil treatment, Li-ESWT may induce a greater increase in penile blood flow and better erectile function than home-based PFMT in middle-aged men with type 2 diabetes mellitus and arteriogenic ED. Nevertheless, home-based PFMT combined with sildenafil treatment may yield greater improvements in these outcomes compared with sildenafil alone in this population. Patients should be informed of the potential benefits, discomforts and inconveniences associated with each treatment to facilitate informed decision-making.

Comment Jens Rassweiler

Objective

The study asked whether low-intensity extracorporeal shockwave therapy (Li-ESWT) and pelvic floor muscle training (PFMT) improve penile blood flow and erectile function in men with type 2 diabetes mellitus and arteriogenic erectile dysfunction, when added to sildenafil treatment.

Study design

This was a three-arm randomised controlled trial with:

• concealed allocation;
• assessor blinding;
• statistician blinding;
• intention-to-treat analysis.
  
  

A total of 90 men aged 35 to 55 years with type 2 diabetes and arteriogenic erectile dysfunction were randomised into three groups:

- Li-ESWT (one session per week for 6 weeks; 3,000 shocks per session; energy flux density of 0.09 mJ/mm²)+ sildenafil

- PFMT (twice daily; 15 short contractions; 15 longer contractions lasting 6 to 10 seconds) + sildenafil

- Sildenafil only

Participants had: type 2 diabetes for more than 5 years;

• erectile dysfunction for more than 6 months;
• arteriogenic erectile dysfunction confirmed by penile Doppler ultrasound;
• body mass index under 30 kg/m²;
• HbA1c below 9%;
• age between 35 and 55 years.
  
  

Notably, all participants were smokers, which is clinically relevant because smoking is a vascular risk factor for erectile dysfunction. All participants completed the study.

Outcomes measurements

Primary outcome

Peak systolic velocity (PSV ) of the right and left cavernosal arteries, measured by penile Doppler ultrasound as an objective measure of penile arterial blood flow.

Secondary outcome

IIEF-5 score, the five-item International Index of Erectile Function. Scores range from worse to better erectile function. Higher scores indicate better function.

Results

Penile blood flow

After 6 weeks Li-ESWT produced the largest improvement in penile blood flow.

Group	Right cavernous artery PSV	Left cavernous artery PSV
Li-ESWT + sildenafil	increased by 21 cm/sec	increased by 21 cm/sec
PFMT + sildenafil	increased by 11 cm/sec	increased by 11 cm/sec
Sildenafil only	increased by 5 cm/sec	increased by 5 cm/sec

The final PSV values in the Li-ESWT group were around 39 cm/sec, which exceeds the usual threshold for normal arterial inflow, often cited as above 30 cm/sec.

Erectile function score

Li-ESWT improved IIEF-5 more than PFMT, and PFMT improved IIEF-5 more than sildenafil alone.

Group	Mean IIEF-5 improvement
Li-ESWT + sildenafil	+3.6 points
PFMT + sildenafil	+2.2 points
Sildenafil only	+1.0 point

However, the authors note that the commonly cited minimal clinically important difference for IIEF-5 is around 4 points, so the Li-ESWT improvement of 3.6 points was close to, but did not clearly exceed, that threshold.

Discussion

Strengths of the study

1. Randomised controlled design

The study used randomisation and concealed allocation, which strengthens internal validity.

2. Objective vascular outcome

Using penile Doppler ultrasound to measure cavernosal artery PSV is a major strength. Many erectile dysfunction trials rely mainly on questionnaires, but this study included an objective physiological measure.

3. Direct comparison of Li-ESWT and PFMT

There has been limited direct evidence comparing shockwave therapy with pelvic floor muscle training, particularly in men with diabetes. This trial addresses an important clinical gap.

4. Clinically relevant population

Men with diabetes commonly experience erectile dysfunction, often with a vascular component. Therefore, the population is clinically meaningful.

5. No dropouts

All 90 participants completed the trial, reducing concern about attrition bias.

Limitations

1. Short follow-up

The study lasted only 6 weeks. This is a major limitation because erectile dysfunction treatments need to show durable benefit. This is especially important for Li-ESWT, which is often proposed as a regenerative or disease-modifying therapy.

2. No sham shockwave group

The study did not include a sham Li-ESWT group. This matters because erectile dysfunction outcomes are sensitive to placebo effects, expectation and psychological conditioning.

Although Doppler PSV is objective, the IIEF-5 score is subjective and could be influenced by treatment expectations.

3. All participants received sildenafil

This design shows the added value of Li-ESWT or PFMT on top of sildenafil, but it does not show whether Li-ESWT or PFMT would be similarly effective without sildenafil.

So the findings should not be interpreted as proving that Li-ESWT or PFMT can replace pharmacological therapy.

4. All participants were smokers

This is unusual and limits generalisability. It may also mean the findings are particularly relevant to men with vascular risk factors, but less applicable to non-smokers.

5. Clinical importance of IIEF-5 change is modest

Although statistically favourable, the IIEF-5 improvement was relatively modest:

• Li-ESWT: +3.6 points;
• PFMT: +2.2 points;
• control: +1.0 point.

The Li-ESWT result was close to the minimal clinically important difference, but PFMT’s effect on subjective function may be smaller from a patient-centred perspective.

Clinical interpretation

The results suggest that Li-ESWT produced a larger physiological improvement in penile arterial blood flow than PFMT or sildenafil alone. This is the strongest and most interesting finding.

PFMT also appeared beneficial, though the effects were smaller. Because PFMT is low-cost, home-based and low-risk, it may still be a reasonable adjunctive option, especially for patients who prefer conservative management or cannot access shockwave therapy.

Li-ESWT may be more attractive for patients seeking a greater improvement, but it requires clinic visits, equipment, trained providers and likely higher cost.

Conclusions

This trial provides encouraging evidence that both low-intensity shockwave therapy and pelvic floor muscle training can improve erectile dysfunction outcomes in men with type 2 diabetes when added to sildenafil.

The apparent ranking of benefit was:

• Li-ESWT + sildenafil — greatest improvement;
• PFMT + sildenafil — moderate improvement;
• sildenafil alone — smallest improvement.
  
  

However, because the study was short, lacked a sham shockwave arm and included a relatively narrow population, the findings should be interpreted as promising rather than definitive. Longer sham-controlled trials are needed to confirm durability and true clinic

Jens Rassweiler