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

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Procedure: Tadalafil (PDE5i)

Study type: Interventional

Funder types: Other

Identifiers

NCT06442020

RS1874/23

Details and patient eligibility

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.

Full 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

Enrollment: 158 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

GROUP 1: LiESWT in association with PDE5i

Experimental group

Description:

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

Treatment:

Procedure: Tadalafil (PDE5i)

GROUP 2: PDE5i alone

Active Comparator group

Description:

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

Treatment:

Procedure: Tadalafil (PDE5i)