RecruitingNot ApplicableNCT06442020
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
Sponsor
Regina Elena Cancer Institute
Enrollment
158 participants
Start Date
Sep 15, 2023
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria4
- 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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Interventions
PROCEDURETadalafil (PDE5i)
Tadalafil at a dose of 5mg/day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06442020
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