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

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction
• Interventions: Procedure: Tadalafil (PDE5i)

• Registration Number: NCT06442020
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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.

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 Timeline

• Study Start: 2023-09-15
• Study First Submitted: 2024-03-29
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-09-15
• Study Completion: 2026-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 1: LiESWT in association with PDE5i	Tadalafil (PDE5i)	Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i
GROUP 2: PDE5i alone	Tadalafil (PDE5i)	Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice

Primary Outcome Measures

Name	Time	Method
Impact of LiESWT	3 years	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

Secondary Outcome Measures

Name	Time	Method
Assess how many patients reach orgasm	3 years	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.
Questionnaires of Quality of life	3 years	Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy