RecruitingNot ApplicableNCT06147791

Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study

Sponsor

A.O.U. Città della Salute e della Scienza

Enrollment

50 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction

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: MALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

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 Criteria10

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.