NCT06717711RecruitingPhase 3
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 30 Nov 2024
- Start date
- 15 Sept 2023
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06717711
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 158
- From 15 Sept 2023 to the primary completion date, 28 Feb 2027
- 2 sites 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.
Prior treatment
- anaesthesiologic contraindications to robotic surgery
- patients submitted to pelvic radiotherapy or androgen deprivation
Other
- patients reporting major postoperative complications (CD≥3)
- cardiovascular contraindications to PDE5i medical treatment
Who the study is looking for
- Patients aged ≤75 yrs;
- PSA \<10 ng/mL
- Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- undergoing nerve sparing RARP;
- preoperative IIEF-5 score ≥ 17;
- First PSA (45d after surgery) \<0.1
- Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology
- ≥ 18 yrs old;
- compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
- patients able to provide a written informed consent for the trial.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS "Fondazione G. Pascale" National Cancer Institute Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| IRCCS Regina Elena National Cancer Institute Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.