Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Fondazione G. Pascale National Cancer Institute
RECRUITING
Naples
IRCCS Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Giuseppe Simone
giuseppe.simone@ifo.it
0652665005
Backup
Riccardo Mastroianni
riccardo.mastroianni@ifo.it
0652665005
Time Frame
Start Date: 2024-08-31
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 158
Treatments
Experimental: PDE5i + LiESWT
Patients receiving LiESWT plus early introduction of PDE5i
Active_comparator: PDE5i alone
Control group, patients receiving PDE5i alone
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov