NCT06147791 Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
| NCT ID | NCT06147791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | A.O.U. Città della Salute e della Scienza |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-10-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 increase the risk of infections.
Eligibility Criteria
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.
Contact & Investigator
Falcone Mr Marco, Physician
PRINCIPAL INVESTIGATOR
Urology
Frequently Asked Questions
Who can join the NCT06147791 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 90 Years, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06147791 currently recruiting?
Yes, NCT06147791 is actively recruiting participants. Contact the research team at marco.falcone@unito.it for enrollment information.
Where is the NCT06147791 trial being conducted?
This trial is being conducted at Torino, Italy, Turin, Italy.
Who is sponsoring the NCT06147791 clinical trial?
NCT06147791 is sponsored by A.O.U. Città della Salute e della Scienza. The principal investigator is Falcone Mr Marco, Physician at Urology. The trial plans to enroll 50 participants.