External scrotal drainage: Application of external scrotal drainage during three-component penile prosthesis placement
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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 ≥ 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.
Primary outcome measure(s)
Post-operative infectious episodes — One month Define the number of post-operative infectious episodes in the two study arms.
Trial sites (2)
Facility
City
Region
Status
SCDU Urologia
Torino
Torino
Not Yet Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Turin
Turin
Recruiting
More A.O.U. Città della Salute e della Scienza trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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