Prosthetics Registry and Outcomes in Urology at Duke

NCT ID: NCT03323645

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Penile Implantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with penile prostheses

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron C Lentz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Raleigh

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00086257

Identifier Type: -

Identifier Source: org_study_id

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