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Clinical Trials in Italy / NCT06717711
Recruiting Phase 3

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

NCT06717711 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Phase 3
Started
2023-09-15
Last updated
2026-08-14

Condition(s) studied

Prostate CarcinomaErectile FunctionGenito Urinary Cancer

Investigational drug(s) / intervention(s)

Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)PDE5 inhibitor (tadalafil) →

Low-intensity Extracorporeal Shock Wave Therapy (LiESWT): LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ/mm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.

PDE5 inhibitor (tadalafil): Phosphodiesterase-5 (PDE5) inhibitors

Study 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

Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 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. Exclusion Criteria: * anaesthesiologic contraindications to robotic surgery * patients submitted to pelvic radiotherapy or androgen deprivation * patients reporting major postoperative complications (CD≥3) * cardiovascular contraindications to PDE5i medical treatment

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
IRCCS "Regina Elena" National Cancer Institute Rome RM Recruiting
IRCCS "Fondazione G. Pascale" National Cancer Institute Naples Italy Recruiting

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Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy Recruiting

Other trials for the same condition

Nerve-SPARing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06717711 on ClinicalTrials.gov ↗ ← All trials in Italy