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

Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Procedure: Tadalafil (PDE5i)

Detailed Description

Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Simone, Doctor; Phone Number: +39 06-5266.5005; Email: giuseppe.simone@ifo.it
• Study Contact Backup: Name: Riccardo Mastroianni, Doctor; Phone Number: +39 06-5266.5005; Email: riccardo.mastroianni@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Giuseppe Simone, Doctor; Phone Number: +39 06-5266.5005; Email: giuseppe.simone@ifo.it
    • Contact: Riccardo Mastroianni, Doctor; Phone Number: +39 06-5266.5005; Email: riccardo.mastroianni@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged ≤75 yrs;
• Low-risk PCa (PSA <10 ng/mL and GS <7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
• preoperative IIEF-5 score ≥ 17;
• First PSA (45d after surgery) <0.2
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP 1: LiESWT in association with PDE5i; Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i	Procedure: Tadalafil (PDE5i); Tadalafil at a dose of 5mg/day
Active Comparator: GROUP 2: PDE5i alone; Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice	Procedure: Tadalafil (PDE5i); Tadalafil at a dose of 5mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of LiESWT	To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess how many patients reach orgasm	Compare the rate of patients achieving orgasm. The International Index of Erectile Function short form (IIEF-5) questionnaire is the recognized tool for assessing erectile function both before surgery and during follow-up.	3 years
Questionnaires of Quality of life	Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.	3 years

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: RS1874/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No