Clinical trial NCT06147791: Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
Official title: Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A (drainage) vs Group B (no drainage)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-operative infectious episodes
timeFrame: One month
Secondary outcomes:
measure: Post-surgical hematoma
timeFrame: One month
measure: Volume of drained material
timeFrame: 24 hour
measure: Manipulation of the activation pump
timeFrame: Up to 12 weeks
measure: Activation of the device
timeFrame: Up to 12 weeks
measure: Use of the penile prosthesis
timeFrame: Up to 12 weeks
measure: Effectiveness of external drainage in subgroups
timeFrame: Up to 12 months
measure: Effectiveness of external drainage in subgroups
timeFrame: Up to 12 months
measure: Effectiveness of external drainage in subgroups
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: SCDU Urologia
city: Turin
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
Study officials:
affiliation: Urology
name: Falcone Mr Marco, Physician
role: PRINCIPAL_INVESTIGATOR
References: