Prostate Cancer Clinical Trial

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Summary

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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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician are eligible for inclusion. Potentially eligible men should also meet the following inclusion criteria for study enrollment:

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1457

Study ID:

NCT01383018

Recruitment Status:

Completed

Sponsor:

Boston Scientific Corporation

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There are 11 Locations for this study

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Urology Centers of Alabama
Homewood Alabama, 35209, United States
El Camino Urology Medical Group
Mountain View California, 94040, United States
Kaiser Permanente
San Diego California, 92154, United States
SIU School of Medicine
Springfield Illinois, 62794, United States
Ark-LA-Tek
Bossier City Louisiana, 71111, United States
Lahey Clinic
Burlington Massachusetts, 01805, United States
The Urology Team
Austin Texas, 78715, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Urology San Antonio Research, PA
San Antonio Texas, 78229, United States
University of Utah
Salt Lake City Utah, 84132, United States
University of Ottawa
Ottawa Ontario, K1H 8, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1457

Study ID:

NCT01383018

Recruitment Status:

Completed

Sponsor:


Boston Scientific Corporation

How clear is this clinincal trial information?

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