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New treatment option for Erectile Dysfunction
Official title Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
ClinicalTrials.gov ID: NCT06442020
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join 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;
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.