RecruitingNot ApplicableNCT07820748

Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder

Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder: A Randomized-Controlled Trial


Sponsor

The University of Hong Kong

Enrollment

40 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the efficacy and safety of linear piezoelectric Li-SWT for erectile dysfunction patients who have poor treatment respond from PDE5i oral treatment. Participants will be randomised to either receive 4 cycles, once per week, of Li-SWT treatment on the penis or the Sham group, where the treatment appears to be identical but the shockwave machine is deactivated. Investigators will compare the before and after treatment erectile function using the IIEF questionnaire of the two groups 1 month after treatment to assess the treatment outcome. After that, the Sham group patient would be offered to receive compensatory Li-SWT treatment and their post treatment response will be assessed. All the patients completing the Li-SWT treatment will be followed up at 6 and 12 months to assess the efficacy and adverse events.


Eligibility

Sex: MALEMin Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham low-intensity shockwave therapy and a medical device called low-intensity shockwave therapy for people with erectile dysfunction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICElow-intensity shockwave therapy

LiSWT with 8Hz, 0.16 mJ/mm2, wave focus penetration depth 10-15mm at corpora cavernosa (2000 shock), crus of the penis (2000 shock), Once per week for 4 weeks

DEVICESham low-intensity shockwave therapy

Sham low-intensity shockwave therapy with device deactivated


Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong

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NCT07820748


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