Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
MALE
NCT06442020

Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.

Led by Regina Elena Cancer Institute · Updated on 2024-06-04

158

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.

CONDITIONS

Official Title

Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 75 years or younger
  • Diagnosed with low-risk prostate cancer (PSA <10 ng/mL, Gleason Score <7, ISUP grade 1, cT1-2a) undergoing nerve-sparing robot-assisted radical prostatectomy
  • Preoperative IIEF-5 score of 17 or higher
  • First PSA measurement 45 days after surgery less than 0.2
  • Able and willing to comply with study procedures and complete IIEF-5 and quality of life questionnaires
  • Able to provide written informed consent for the trial
Not Eligible

You will not qualify if you...

  • Contraindications to robotic surgery related to anesthesia
  • Previous pelvic radiotherapy or androgen deprivation therapy
  • Major postoperative complications classified as Clavien-Dindo grade 3 or higher
  • Cardiovascular contraindications to PDE5 inhibitor treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

"Regina Elena" National Cancer Institute

Rome, Italy, 00144

Actively Recruiting

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Research Team

G

Giuseppe Simone, Doctor

CONTACT

R

Riccardo Mastroianni, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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