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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with drainage | Experimental |
| |
| Group without drainage | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External scrotal drainage | Device | Application of external scrotal drainage during three-component penile prosthesis placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative infectious episodes | Define the number of post-operative infectious episodes in the two study arms. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical hematoma | Define the risk of post-surgical hematoma formation in the two study arms. | One month |
| Volume of drained material | Evaluate the volume of drained material in the group with external drainage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Falcone Mr Marco, Physician | Contact | 0116336594 | marco.falcone@unito.it | |
| Preto Mr Mirko, Physician | Contact | 0116336594 | mirko.preto@unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Falcone Mr Marco, Physician | Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCDU Urologia | Not yet recruiting | Torino | Torino | 10126 | Italy |
The data will be shared only among physician participating in the study.
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Group A (drainage) vs Group B (no drainage)
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| 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months |
| A.O.U. Città della Salute e della Scienza di Torino | Recruiting | Turin | Turin | 10126 | Italy |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |