Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

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

Status

Enrolling

Conditions

Erectile Dysfunction

Treatments

Device: External scrotal drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT06147791

833.300

Details and patient eligibility

About

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.

Full 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 generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.

Enrollment

50 estimated patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.