Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery
Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
ARM I (LiSWT)
ARM II (sham LiSWT)
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.
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.