Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
MALE
NCT06147791

Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

Led by A.O.U. Città della Salute e della Scienza · Updated on 2025-01-24

50

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

Who Can Participate

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent given voluntarily
  • Genetically male patient
  • Age 18 years or older
  • Having erectile dysfunction of variable or multifactorial causes
  • Erectile dysfunction not responsive to iPDE-5 medication
  • Erectile dysfunction that is unresponsive or not tolerated to treatment
Not Eligible

You will not qualify if you...

  • No signed written informed consent
  • Age younger than 18 years
  • Genetically female patient
  • Active infection in the penile or scrotal area
  • Active systemic infection
  • Immunosuppressed condition
  • Blood disorders increasing bleeding risk
  • Peyronie's Disease requiring simultaneous plaque surgery
  • Any condition that poses significant risk, confounds results, or interferes with study participation
  • Unable to participate in follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

SCDU Urologia

Torino, Torino, Italy, 10126

Not Yet Recruiting

2

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

Turin, Turin, Italy, 10126

Actively Recruiting

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Research Team

F

Falcone Mr Marco, Physician

CONTACT

P

Preto Mr Mirko, Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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