An interventional study of low-intensity shockwave therapy and Sham low-intensity shockwave therapy in Erectile Dysfunction, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to male participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: low-intensity shockwave therapy
Sham comparator with the device deactivated
Device: Sham low-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
Sham low-intensity shockwave therapy with device deactivated
Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment
Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction. This outcome measure reports the proportion of participants achieving an improvement in IIEF score compared to baseline.
Time frame: 1 month after Sham/LiSWT
Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function (IIEF) score
The International Index of Erectile Function (IIEF) is a self-administered questionnaire used to assess erectile function.Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction. This outcome measure reports the proportion of participants achieving a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
Time frame: 1 month
Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 and 12 months after treatment
IIEF is a self-administered questionnaire used to assess erectile function. Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction. This outcome measure reports the proportion of participants achieving a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
Time frame: 6 and 12 months after treatment
Erectile hardness score (EHS) at 1,6, 12 months after treatment
vertical score assessing penile hardness on a 4-point single-item scale ranging from 1 to 4, where 1 indicates "penis is larger, but not hard" and 4 indicates "penis is completely hard and fully rigid." Higher scores indicate better erectile function/rigidity.
Time frame: 1, 6, 12 months after LiSWT treatment
Side effects and safety profile
e.g. tolerability, pain using the visual analogue scale, bleeding, bruising, penile plaque, penile deformity Safety and tolerability will be evaluated by recording the incidence, severity, and type of all treatment-related adverse events. Pain will be assessed using a Visual Analogue Scale (VAS), a single-item numeric scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain intensity. Specific adverse events evaluated include penile pain, bleeding, bruising, formation of penile plaque, and penile deformity.
Time frame: From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 115 non-industry interventional studies with no phase under Erectile Dysfunction, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 11 months is below that.
Counting every sponsor, half of 137 studies reached it within 32 months; a quarter within 14 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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