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Recruiting NCT06442020

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

Trial Parameters

Condition Erectile Dysfunction
Sponsor Regina Elena Cancer Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 158
Sex MALE
Min Age 18 Years
Max Age 75 Years
Start Date 2023-09-15
Completion 2025-09-15
Interventions
Tadalafil (PDE5i)

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.

Eligibility Criteria

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.

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