Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Recruiting now · Not applicable
Conditions studied: Erectile Dysfunction
In brief
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.
Key facts
- Study ID
- NCT06442020
- Run by
- Regina Elena Cancer Institute
- People needed
- 158
- Starts
- 2023-09-15
- Expected to finish
- 2026-09-15
- Last updated by the study team
- 2024-06-04
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- "Regina Elena" National Cancer Institute — Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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