Prosthetics Registry and Outcomes in Urology at Duke | NCT03323645

Studies
Prosthetics Registry and Outcomes in Urology at Duke

NCT03323645

Sponsor

Duke University

Status

Terminated

Last Update Posted

Jun 29, 2020Actual

Enrollment

190Actual

Phase

Not provided

Conditions

Penile Implantation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

change of study structure and resource allocation

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Mar 20, 2020Actual

Completion Date

Mar 20, 2020Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2020

Last Update Posted Date

Jun 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Label	Type	Description	Intervention Names
Patients with penile prostheses

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Inability to provide informed consent

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men with end-stage erectile dysfunction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aaron C Lentz, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke Raleigh		Raleigh	North Carolina	27609	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided