Phase
Condition
Prostate Cancer, Early, Recurrent
Male Hormonal Deficiencies/abnormalities
Erectile Dysfunction
Treatment
Survey Administration
Duplex Ultrasound
Medical Device Usage and Evaluation
Clinical Study ID
Ages 18-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of thestudy
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 eachfollow-up visit
Be willing to stop all erectile aids (e.g. prescription and non-prescriptionerectile medications not part of this study, penile injections, vacuum erectiondevices, constriction rings) during the screening and study period
Exclusion
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/hormonetherapy 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 signingconsent
Subject has received platelet-rich plasma (PRP) within 3 months of signingconsent
Subject has received stem cell within 6 months of signing consent
Subject has any condition or exhibits behavior that indicates to the principleinvestigator (PI) that the subject is unlikely to be compliant with studyprocedures and visits
Cognitively/decisionally-impaired individuals
Study Design
Study Description
Connect with a study center
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
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