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NCT Number: NCT07820748

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

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Location status: Recruiting

Location contact

Dr Hung, MBBS

CONTACT

[email protected]

852-22554852

Pui Long Wilson Hung, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment

    Time frame: 1 month after Sham/LiSWT

    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.

Secondary outcomes

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

    Time frame: 1 month

    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.

  2. 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

    Time frame: 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.

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

    Time frame: 1, 6, 12 months after LiSWT 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.

  4. Side effects and safety profile

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Hung, MBBS

CONTACT

[email protected]

852-22554852

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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