Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

NCT06147791 | Recruiting DMC

• 1 other identifier: 833.300
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Post-operative infectious episodes

  Define the number of post-operative infectious episodes in the two study arms.

  One month

Secondary Outcomes (8)

• Post-surgical hematoma

  One month

• Volume of drained material

  24 hour

• Manipulation of the activation pump

  Up to 12 weeks

• Activation of the device

  Up to 12 weeks

• Use of the penile prosthesis

  Up to 12 weeks

Study Arms (2)

Group with drainage

EXPERIMENTAL

Device: External scrotal drainage

Group without drainage

NO INTERVENTION

Interventions

External scrotal drainage DEVICE

Application of external scrotal drainage during three-component penile prosthesis placement

Group with drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (2)

SCDU Urologia

Torino, Torino, 10126, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza di Torino

Turin, Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Falcone Mr Marco, Physician

  Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Falcone Mr Marco, Physician

CONTACT

0116336594; marco.falcone@unito.it

Preto Mr Mirko, Physician

CONTACT

0116336594; mirko.preto@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group A (drainage) vs Group B (no drainage)

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: November 28, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2033
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)