Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
ConditionErectile Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorA.O.U. Città della Salute e della Scienza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Absence of signed written informed consent (Appendix B).
Age <18 years.
Genetically female patients.
Patient with active peno-scrotal infection.
Trial design
Design model
Parallel
Treatments tested in this trial
External scrotal drainage
DeviceApplication of external scrotal drainage during three-component penile prosthesis placement
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group with drainageExperimental treatment 1 intervention
Group B: Group without drainageNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post-operative infectious episodes
Define the number of post-operative infectious episodes in the two study arms.
Time frame
One monthSecondary outcomes
1
Post-surgical hematoma
Define the risk of post-surgical hematoma formation in the two study arms.
Time frame
One month2
Volume of drained material
Evaluate the volume of drained material in the group with external drainage.
Time frame
24 hour3
Manipulation of the activation pump
Define the time elapsed between surgery and subsequent manipulation of the activation pump in the two study arms, usually 2 weeks.
Time frame
Up to 12 weeks4
Activation of the device
Define the time elapsed between the surgical intervention and the subsequent activation of the device in the two study arms, usually 3 weeks.
Time frame
Up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov