Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: External scrotal drainage

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Falcone Mr Marco, Physician; Phone Number: 0116336594; Email: marco.falcone@unito.it
• Study Contact Backup: Name: Preto Mr Mirko, Physician; Phone Number: 0116336594; Email: mirko.preto@unito.it

Study Locations

• Italy
  • Torino, Italy, 10126
    • Not yet recruiting
    • SCDU Urologia
    • Contact: Falcone Mr Marco, Physician; Phone Number: 0116336594; Email: marco.falcone@unito.it
    • Contact: Preto Mr Mirko, Physician; Phone Number: 0116336594; Email: mirko.preto@unito.it
  • Turin, Italy, 10126
    • Recruiting
    • A.O.U. Città della Salute e Della Scienza di Torino
    • Contact: Mirko M Preto, MD, PhD; Phone Number: +39 0116335530; Email: mirko.preto@unito.it
    • Contact: Marco M Falcone, MD, PhD; Phone Number: +39 0116335530; Email: marco.falcone@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group with drainage	Device: External scrotal drainage; Application of external scrotal drainage during three-component penile prosthesis placement
No Intervention: Group without drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative infectious episodes	Define the number of post-operative infectious episodes in the two study arms.	One month

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: A.O.U. Città della Salute e della Scienza
• Investigators: Principal Investigator: Falcone Mr Marco, Physician, Urology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2033

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: 833.300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be shared only among physician participating in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No