LiSWT for Nerve Sparing Radical Prostatectomy ED

PRIMARY OBJECTIVE:

I. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication.

SECONDARY OBJECTIVES:

I. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment.

II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

ARM II: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Inclusion criteria

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Men aged 18-80 diagnosed with localized prostate cancer
• Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment
• Undergo the nerve-sparing radical prostatectomy procedure
• Be taking PDE5i medication for the entirety of the study (normal course of care)
• Be in a sexual relationship with a partner for at least 3 months
• Be willing to attempt sexual activity during the screening period and before each follow-up visit
• Be willing to stop all erectile aids (e.g. prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, constriction rings) during the screening and study period

Exclusion criteria

• • Subject does not speak or understand English

• Subject has been treated with acoustic wave previously
• Subject has had prior penile surgery
• Patients with pacemakers or implantable defibrillators
• Patients who are using devices which are sensitive to electromagnetic radiation
• Patients who are found to have metastatic disease and require radiation/hormone therapy before initiation of shockwave/sham treatments
• Subject has lesions or active infections on the penis or perineum
• Subject is unwilling to remove piercings from the genital region
• Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week
• Subject has received an investigational drug within 30 days prior to signing consent
• Subject has received platelet-rich plasma (PRP) within 3 months of signing consent
• Subject has received stem cell within 6 months of signing consent
• Subject has any condition or exhibits behavior that indicates to the principle investigator (PI) that the subject is unlikely to be compliant with study procedures and visits
• Cognitively/decisionally-impaired individuals