Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

Erectile Dysfunction Clinical Trial

Official title:

Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147791
• Other study ID #: 833.300
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2033

Study information

• Verified date: November 2023
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Falcone Mr Marco, Physician
• Phone: 0116336594
• Email: marco.falcone[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2033
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• External scrotal drainage
Application of external scrotal drainage during three-component penile prosthesis placement

Locations

Country	Name	City	State
Italy	SCDU Urologia	Torino
Italy	A.O.U. Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative infectious episodes	Define the number of post-operative infectious episodes in the two study arms.	One month
Secondary	Post-surgical hematoma	Define the risk of post-surgical hematoma formation in the two study arms.	One month
Secondary	Volume of drained material	Evaluate the volume of drained material in the group with external drainage.	24 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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