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

Official record

Identifier

NCT06717711

Recruiting locations

country

Italy

Interventions studied

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

Lead sponsor

Regina Elena Cancer Institute

Target enrolment

158 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Dec 5, 2024

Last updated on the registry

Aug 14, 2026

Age

18 Years – 75 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Prostate Cancer