Prosthetics Registry and Outcomes in Urology at Duke

Penile Implantation Clinical Trial

— PROUD  

Official title:

Prosthetics Registry and Outcomes in Urology at Duke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03323645
• Other study ID #: Pro00086257
• Status: Terminated
• Start date: December 1, 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: April 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. The study team will collect retrospective data from subjects at Duke University and Duke Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1, 1996 onward. Prospective data will only be collected from patients seeking care with Dr. Lentz in Duke Raleigh.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male

• Adult (18 years of age or older)

• Inflatable or semi-rigid penile prosthesis placed

Exclusion Criteria:

• Inability to provide informed consent

Related Conditions & MeSH terms

• Penile Implantation

Locations

Country	Name	City	State
United States	Duke Raleigh	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses.		up to 5 years