Evaluating scrotal drainage during penile prosthesis surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized study aims to assess whether the use of external scrotal drainage during penile prosthesis implantation can reduce post-operative complications without increasing the risk of infections. Patients will be randomly assigned to two groups: one receiving drainage and the other not. The study will involve monitoring for hematomas and surgical site infections through regular check-ups over a five-year period. The methodology includes the use of antibiotic prophylaxis and a structured follow-up schedule to evaluate outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• A.O.U. Città della Salute e della Scienza di Torino
  Turin, Turin, Italy Recruiting
• SCDU Urologia
  Torino, Torino, Italy Not yet recruiting

Study contacts

• Principal investigator: Falcone Mr Marco, Physician — Urology
• Study coordinator: Falcone Mr Marco, Physician
• Email: marco.falcone@unito.it
• Phone: 0116336594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.