Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
NCT ID: NCT06442020
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2023-09-15
2026-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GROUP 1: LiESWT in association with PDE5i
Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i
Tadalafil (PDE5i)
Tadalafil at a dose of 5mg/day
GROUP 2: PDE5i alone
Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice
Tadalafil (PDE5i)
Tadalafil at a dose of 5mg/day
Interventions
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Tadalafil (PDE5i)
Tadalafil at a dose of 5mg/day
Eligibility Criteria
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Inclusion Criteria
* 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
* patients submitted to pelvic radiotherapy or androgen deprivation;
* patients reporting major postoperative complications (CD≥3);
* cardiovascular contraindications to PDE5i medical treatment.
18 Years
75 Years
MALE
No
Sponsors
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Regina Elena Cancer Institute
OTHER
Responsible Party
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Locations
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"Regina Elena" National Cancer Institute
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS1874/23
Identifier Type: -
Identifier Source: org_study_id
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