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Prosthetics Registry and Outcomes in Urology at Duke (PROUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03323645
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Penile Implantation

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prosthetics Registry and Outcomes in Urology at Duke
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Patients with penile prostheses

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with end-stage erectile dysfunction.

Inclusion Criteria:

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

Exclusion Criteria:

- Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03323645

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Contact: Evan C Carlos, MD 9167996247

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United States, North Carolina
Duke Raleigh Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Evan C Carlos, MD    916-799-6247   
Contact: Aaron C Lentz, MD    9198625600   
Sponsors and Collaborators
Duke University
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Principal Investigator: Aaron C Lentz, MD Duke University

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Responsible Party: Duke University Identifier: NCT03323645     History of Changes
Other Study ID Numbers: Pro00086257
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
prostate cancer
erectile dysfunction
penile prosthesis