An interventional study of External scrotal drainage in Erectile Dysfunction, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 2 sites in Italy. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by A.O.U. Città della Salute e della Scienza · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: External scrotal drainage
Application of external scrotal drainage during three-component penile prosthesis placement
Post-operative infectious episodes
Define the number of post-operative infectious episodes in the two study arms.
Time frame: One month
Post-surgical hematoma
Define the risk of post-surgical hematoma formation in the two study arms.
Time frame: One month
Volume of drained material
Evaluate the volume of drained material in the group with external drainage.
Time frame: 24 hour
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 weeks
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 weeks
Use of the penile prosthesis
Define the time elapsed between surgery and the use of the penile prosthesis for sexual activity in the two study arms, usually 4 weeks after surgery.
Time frame: Up to 12 weeks
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the IIEF questionnaires.
Time frame: Up to 12 months
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the SSIPI questionnaires.
Time frame: Up to 12 months
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the QoLPSS questionnaires.
Time frame: Up to 12 months
Plan to share: No — The data will be shared only among physician participating in the study.
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A.O.U. Città della Salute e della Scienza