Prosthetics Registry and Outcomes in Urology at Duke (PROUD)

June 25, 2020 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Duke Raleigh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with end-stage erectile dysfunction.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with penile prostheses

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Aaron C Lentz, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00086257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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