Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: External scrotal drainage.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
Overview
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.
Interventions
- Device External scrotal drainage
Application of external scrotal drainage during three-component penile prosthesis placement
Primary outcome measures
- Post-operative infectious episodes [Time frame: One month]
Secondary outcome measures (8)
- Post-surgical hematoma [Time frame: One month]
- Volume of drained material [Time frame: 24 hour]
- Manipulation of the activation pump [Time frame: Up to 12 weeks]
- Activation of the device [Time frame: Up to 12 weeks]
- Use of the penile prosthesis [Time frame: Up to 12 weeks]
- Effectiveness of external drainage in subgroups [Time frame: Up to 12 months]
- Effectiveness of external drainage in subgroups [Time frame: Up to 12 months]
- Effectiveness of external drainage in subgroups [Time frame: Up to 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- SCDU Urologia — Torino
- A.O.U. Città della Salute e della Scienza di Torino — Turin
Identifiers
NCT: NCT06147791 · 833.300