NCT05877144Completed
LiSWT for Nerve Sparing Radical Prostatectomy ED
Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 15 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 5 May 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT05877144
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 6 Jul 2023 to the primary completion date, 30 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.