Actively Recruiting
Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: A Prospective Randomized Study
Led by A.O.U. Città della Salute e della Scienza · Updated on 2025-01-24
50
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using an external scrotal drainage during penile prosthetic surgery can lower the risk of post-operative complications without increasing infections in men with erectile dysfunction. This prospective randomized study involves adult male patients who have erectile dysfunction that does not respond to medication. The study aims to compare outcomes between patients receiving drainage and those who do not during penile prosthesis implantation. Participants are randomly assigned to one of two groups: Group A receives external scrotal drainage placed during surgery for 24 hours, while Group B does not receive drainage. All patients undergo implantation of a three-component penile prosthesis with antibiotic prophylaxis before and after surgery. The drainage is removed on the first post-operative day. The degree of hematoma is assessed using a standardized scale. Follow-up visits occur at 7, 15, and 30 days after surgery to monitor hematoma and surgical site infections. Additional check-ups happen monthly for the first 3 months, then every 3 months up to one year, and annually up to five years after surgery. Researchers also track the time of penile prosthesis use. The main outcome measured is the incidence of post-operative infections within one month.
CONDITIONS
Official Title
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given voluntarily
- Genetically male patient
- Age 18 years or older
- Having erectile dysfunction of variable or multifactorial causes
- Erectile dysfunction not responsive to iPDE-5 medication
- Erectile dysfunction that is unresponsive or not tolerated to treatment
You will not qualify if you...
- No signed written informed consent
- Age younger than 18 years
- Genetically female patient
- Active infection in the penile or scrotal area
- Active systemic infection
- Immunosuppressed condition
- Blood disorders increasing bleeding risk
- Peyronie's Disease requiring simultaneous plaque surgery
- Any condition that poses significant risk, confounds results, or interferes with study participation
- Unable to participate in follow-up visits
AI-Screening
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Trial Site Locations
Total: 2 locations
1
SCDU Urologia
Torino, Torino, Italy, 10126
Not Yet Recruiting
2
A.O.U. Città della Salute e della Scienza di Torino
Turin, Turin, Italy, 10126
Actively Recruiting
Research Team
F
Falcone Mr Marco, Physician
P
Preto Mr Mirko, Physician
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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