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 range
18 Years – 80 Years
Sex
MALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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