Prosthetics Registry and Outcomes in Urology at Duke

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03323645

Acronym

PROUD

Enrollment

190

Registered

2017-10-27

Start date

2017-12-01

Completion date

2020-03-20

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penile Implantation

Keywords

prostate cancer, erectile dysfunction, penile prosthesis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male * Adult (18 years of age or older) * Inflatable or semi-rigid penile prosthesis placed

Exclusion criteria

\- Inability to provide informed consent

Design outcomes

Primary

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

Countries

United States

Outcome results