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

Sponsor: The University of Hong Kong • ClinicalTrials.gov ID: NCT07820748

Registry updated: 2026-09-15

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Description

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.

Interventions

low-intensity shockwave therapy (Device)
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
Sham low-intensity shockwave therapy (Device)
Sham low-intensity shockwave therapy with device deactivated

Eligibility criteria

Inclusion Criteria: * Male * Age 30-80 years * ED for at least 6 months, defined by IIEF-EF score 8-21 (moderate - mild) * Sexually active in a stable, heterosexual relationship of more than 3 months duration. * Agree to comply with all study related tests/procedures * Morning serum testosterone \>12nmol/L * Inadequate response after at least 4 attempts using highest tolerated PDE5i Exclusion Criteria: * Previous penile surgery (e.g. penile lengthening, penile cancer surgery, penile plication, grafting, penile implant). * Previous history of priapism or penile fracture * Morning serum testosterone level \<12nmol/L * Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded * Psychogenic ED as determined by study investigator * Anatomical (Peyronie's Disease or penile curvature) abnormality * Neurological disease (Parkinson's, spinal cord injury) * Anti-coagulation therapy and/or INR \>1.5 (Patients on aspirin are eligible) 7 * Current or prior history of sexually transmitted disease * Tumor tissue/Treatment for cancer in the penile or pelvic region in past 5 years * Electronic devices implanted in the body (e.g. cardiac pacemaker, deep brain stimulator, spinal cord neurostimulator etc.) * Any other medical conditions or medical history that are deemed unsafe or high risk for the study treatment per investigator's discretion

Conditions

Erectile Dysfunction

Locations

Queen Mary Hospital — Hong Kong, Hong Kong

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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