Status:
RECRUITING
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
Lead Sponsor:
A.O.U. Città della Salute e della Scienza
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-90 years
Phase:
NA
Brief 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 incr...
Detailed Description
After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2033
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06147791
Start Date
October 1 2023
End Date
October 1 2033
Last Update
January 24 2025
Active Locations (2)
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1
SCDU Urologia
Torino, Torino, Italy, 10126
2
A.O.U. Città della Salute e della Scienza di Torino
Turin, Turin, Italy, 10126