Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Recruiting
Phase 3
Interventional Study
Prostate Carcinoma
Erectile Function
Genito Urinary Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 158 (estimated)
- Sponsor
- Regina Elena Cancer Institute · Other
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About This Trial
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 L…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts