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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442020
• Other study ID #: RS1874/23
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 15, 2026

Study information

• Verified date: May 2024
• Source: Regina Elena Cancer Institute
• Contact: Giuseppe Simone, Doctor
• Phone: 06-5266.5005
• Email: giuseppe.simone[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• Tadalafil (PDE5i)
Tadalafil at a dose of 5mg/day

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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