Evaluating scrotal drainage during penile prosthesis surgery
Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
This study is testing if using a drainage tube during penile prosthesis surgery can help prevent complications without raising the risk of infections for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | A.O.U. Città della Salute e della Scienza Academic / other |
| Locations | 2 sites (Torino, Torino and 1 other locations) |
| Trial ID | NCT06147791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are genetically male patients aged 18 and older suffering from erectile dysfunction that is unresponsive to other treatments.
Not a fit: Patients with active infections, immunosuppression, or specific conditions like Peyronie's Disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer complications and improved recovery for patients undergoing penile prosthesis surgery.
How similar studies have performed: While this approach is being evaluated in this study, similar interventions have shown promise in reducing surgical complications in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Torino, Torino and 1 other locations
- SCDU Urologia — Torino, Torino, Italy (Not_yet_recruiting)
- A.O.U. Città della Salute e della Scienza di Torino — Turin, Turin, Italy (Recruiting)
Study contacts
- Principal investigator: Falcone Mr Marco, Physician — Urology
- Study coordinator: Falcone Mr Marco, Physician
- Email: marco.falcone@unito.it
- Phone: 0116336594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.