๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion 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 โฅ 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
Exclusion Criteria:
* 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 study.
* The patient declares that it will be impossible for him to participate in follow-up consultations.
๐
What it tests
- External scrotal drainage
SCDU Urologia
Torino, Italy
A.O.U. Cittร della Salute e della Scienza di Torino
Turin, Italy
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.