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

NCT06442020 | Recruiting

• 1 other identifier: RS1874/23
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assess how many patients reach orgasm

  3 years

• Questionnaires of Quality of life

  3 years

Study Arms (2)

GROUP 1: LiESWT in association with PDE5i

EXPERIMENTAL

Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i

Procedure: Tadalafil (PDE5i)

GROUP 2: PDE5i alone

ACTIVE COMPARATOR

Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice

Procedure: Tadalafil (PDE5i)

Interventions

Tadalafil (PDE5i) PROCEDURE

Tadalafil at a dose of 5mg/day

GROUP 1: LiESWT in association with PDE5i; GROUP 2: PDE5i alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Giuseppe Simone, Doctor

CONTACT

06-5266.5005; giuseppe.simone@ifo.it

Riccardo Mastroianni, Doctor

CONTACT

06-5266.5005; riccardo.mastroianni@ifo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: June 4, 2024
• Study Start: September 15, 2023
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

IT (1)