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

NCT07820748 | Recruiting

• 1 other identifier: LiSWTED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; shockwave treatment; PDE5i non responder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function (IIEF) score

  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

  6 and 12 months after treatment

• Erectile hardness score (EHS) at 1,6, 12 months after treatment

  1, 6, 12 months after LiSWT treatment

• Side effects and safety profile

  From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment

Study Arms (2)

LiSWT

EXPERIMENTAL

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

SHAM COMPARATOR

Sham comparator with the device deactivated

Device: Sham low-intensity shockwave therapy

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

LiSWT

Sham low-intensity shockwave therapy DEVICE

Sham low-intensity shockwave therapy with device deactivated

Sham

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Erectile dysfunction is a male only disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Dr Hung, MBBS

CONTACT

852-22554852; hpl826@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: September 15, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-06

Locations

HK (1)