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

N/ARecruitingNCT07820748

The University of Hong Kong40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Erectile Dysfunction

Interventions

Eligibility

Sex: MALEMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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