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New treatment option for Erectile Dysfunction
Official title Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
ClinicalTrials.gov ID: NCT06147791
What this study is testing
- What it's testing
- The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
- 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 90, men only
You may be able to join if
- Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations...
- Genetically male patient.
- Age ≥ 18 years.
- Patient suffering from ED of variable and/or multifactorial etiology.
- Patient suffering from ED not responsive to iPDE-5.
You likely can't join if
- Absence of signed written informed consent (Appendix B).
- Age \<18 years.
- Genetically female patients.
- Patient with active peno-scrotal infection.
- Patient with active systemic infection.
- Immunosuppressed patient.
See the full eligibility criteria
- Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).
- Genetically male patient.
- Age ≥ 18 years.
- Patient suffering from ED of variable and/or multifactorial etiology.
- Patient suffering from ED not responsive to iPDE-5.
- Patient suffering from unresponsive or non-tolerant ED
- Absence of signed written informed consent (Appendix B).
- Age \<18 years.
- Genetically female patients.
- Patient with active peno-scrotal infection.
- Patient with active systemic infection.
- Immunosuppressed patient.
- Patient with haematological pathologies that may cause an increased risk of bleeding.
- Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.
- Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the...
- The patient declares that it will be impossible for him to participate in follow-up consultations.
The study team makes the final eligibility decision.
Where it's taking place
- Torino, Torino, Italy
- Turin, Turin, 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 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torino, Torino, Italy; Turin, Turin, 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.