LiSWT for Nerve Sparing Radical Prostatectomy ED (NCT05877144) | Clinical Trial Compass
CompletedNot Applicable
LiSWT for Nerve Sparing Radical Prostatectomy ED
United States8 participantsStarted 2023-07-06
Plain-language summary
This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.
Who can participate
Age range18 Years – 80 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with…
What they're measuring
1
Patient reported sexual function
Timeframe: At 6 months post low intensity shockwave therapy (LiSWT) initiation
2
Patient reported sexual function
Timeframe: At 6 months post low intensity shockwave therapy (LiSWT) initiation