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PROPPER Prospective Registry of Outcomes With Penile Prosthesis

NCT ID: NCT01383018

Last Updated: 2021-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1457 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-13

Study Completion Date

2018-07-25

Brief Summary

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The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

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Detailed Description

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A prospective, multi-center, observational registry to be conducted at multiple sites throughout the United States and Canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. The physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

Conditions

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Erectile Dysfunction Impotence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMS penile prosthesis receipients

Men for whom an AMS penile prosthesis is recommended

AMS Penile Prosthesis Devices

Intervention Type DEVICE

Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Interventions

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AMS Penile Prosthesis Devices

Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Intervention Type DEVICE

Other Intervention Names

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AMS 700 AMS Ambicor AMS Spectra

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent prior to enrollment (if applicable).
* Willing to be seen or contacted by phone by the investigator and answer at least 2 questions related to satisfaction and device use 1 year following implantation of an AMS penile prosthesis.

Exclusion Criteria

\- Men who are deemed by their physician to be not suitable for a penile implant will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Ark-LA-Tek

Anthony J. Bella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Edward Karpman, MD

Role: PRINCIPAL_INVESTIGATOR

El Camino Urology Medical Group

LeRoy Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Urology San Antonio Research PA

Bryan T Kansas, MD

Role: PRINCIPAL_INVESTIGATOR

The Urology Team

Brian Christine, MD

Role: PRINCIPAL_INVESTIGATOR

Urology Centers of Alabama

Kevin McVary, MD

Role: PRINCIPAL_INVESTIGATOR

SIU School of Medicine

James Hotaling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Mohit Khera, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Eugene Rhee, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Urology Centers of Alabama

Homewood, Alabama, United States

Site Status

El Camino Urology Medical Group

Mountain View, California, United States

Site Status

Kaiser Permanente

San Diego, California, United States

Site Status

SIU School of Medicine

Springfield, Illinois, United States

Site Status

Ark-LA-Tek

Bossier City, Louisiana, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

The Urology Team

Austin, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Urology San Antonio Research, PA

San Antonio, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U0552

Identifier Type: -

Identifier Source: org_study_id

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