Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

NCT ID: NCT06147791

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2033-10-01

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.

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 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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group with drainage

Group Type: EXPERIMENTAL

External scrotal drainage

Intervention Type: DEVICE

Application of external scrotal drainage during three-component penile prosthesis placement

Group without drainage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

External scrotal drainage

Application of external scrotal drainage during three-component penile prosthesis placement

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Mirko Preto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Falcone Mr Marco, Physician

Role: PRINCIPAL_INVESTIGATOR

Urology

Locations

SCDU Urologia

Torino, Torino, Italy

Site Status: NOT_YET_RECRUITING

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

Turin, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Falcone Mr Marco, Physician

Role: CONTACT

marco.falcone@unito.it

0116336594

Preto Mr Mirko, Physician

Role: CONTACT

mirko.preto@unito.it

0116336594

Facility Contacts

Falcone Mr Marco, Physician

Role: primary

marco.falcone@unito.it

0116336594

Preto Mr Mirko, Physician

Role: backup

mirko.preto@unito.it

0116336594

Mirko M Preto, MD, PhD

Role: primary

mirko.preto@unito.it

+39 0116335530

Marco M Falcone, MD, PhD

Role: backup

marco.falcone@unito.it

+39 0116335530

Other Identifiers

833.300

Identifier Type: -

Identifier Source: org_study_id