NCT03323645

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

June 29, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

October 19, 2017

Last Update Submit

June 25, 2020

Conditions

Penile Implantation

Keywords

prostate cancererectile dysfunctionpenile prosthesis

Outcome Measures

Primary Outcomes (1)

  • Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses.

    up to 5 years

Study Arms (1)

Patients with penile prostheses

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with end-stage erectile dysfunction.

You may qualify if:

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

You may not qualify if:

  • \- Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Raleigh

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsErectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Aaron C Lentz, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 27, 2017

Study Start

December 1, 2017

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

June 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)