Piezoelectric Low-Intensity Shockwave Therapy for erectile dysfunction in PDE5i nonresponders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with erectile dysfunction who have not adequately responded to PDE5 inhibitors are randomized to receive four weekly sessions of active Li-SWT or a sham treatment. Erectile function will be measured with the IIEF questionnaire before and after treatment, with follow-up at 6 and 12 months to monitor durability and safety. After the initial phase, sham participants may cross over to receive active Li-SWT and will have their response assessed. The trial emphasizes safety and efficacy in a limited, age-diverse adult population.

Why it matters

Who can join: the full rules

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

Where it's running

• Queen Mary Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Dr Hung, MBBS
• Email: hpl826@ha.org.hk
• Phone: 852-22554852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.