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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: low-intensity shockwave therapy; Device: Sham low-intensity shockwave therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Hung, MBBS; Phone Number: 852-22554852; Email: hpl826@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Dr Hung, MBBS; Phone Number: 852-22554852; Email: hpl826@ha.org.hk
    • Principal Investigator: Pui Long Wilson Hung, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiSWT; 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; 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 Comparator: Sham; Sham comparator with the device deactivated	Device: Sham low-intensity shockwave therapy; Sham low-intensity shockwave therapy with device deactivated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after Sham/LiSWT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: erectile dysfunction; shockwave treatment; PDE5i non responder
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: LiSWTED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No