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.
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.
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
Crossover
low-intensity shockwave therapy
DeviceLiSWT 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
DeviceSham 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.
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.
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.
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.
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.
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The University of Hong Kong
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
