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PROPPER Prospective Registry of Outcomes With Penile Prosthesis (PROPPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01383018
Recruitment Status : Active, not recruiting
First Posted : June 28, 2011
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Erectile Dysfunction Impotence Device: AMS Penile Prosthesis Devices

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 1467 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
Actual Study Start Date : June 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
AMS penile prosthesis receipients
Men for whom an AMS penile prosthesis is recommended
Device: AMS Penile Prosthesis Devices
Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
Other Names:
  • AMS 700
  • AMS Ambicor
  • AMS Spectra

Outcome Measures

Primary Outcome Measures :
  1. Penile prosthesis durability and patient satisfaction [ Time Frame: 1 to 5 years post-treatment ]
    Penile prosthesis durability and patient satisfaction measured using non-validated, standardized patient questions.

  2. Penile prosthesis complications [ Time Frame: Implantation through up to 5 years post-treatment ]
    Penile prosthetic device complications as reported throughout post-implantation follow-up

Secondary Outcome Measures :
  1. Penile prosthesis effectiveness, patient satisfaction and quality of life [ Time Frame: Baseline through up to 5 years post-treatment ]
    Penile prosthesis effectiveness for erectile restoration, patient satisfaction and quality of life measurements to be performed using validated disease-specific and general HR-QoL questionnaires (per investigators' standard of care).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with ED in the United States and Canada.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383018

United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, California
El Camino Urology Medical Group
Mountain View, California, United States, 94040
Kaiser Permanente
San Diego, California, United States, 92154
United States, Illinois
SIU School of Medicine
Springfield, Illinois, United States, 62794-9664
United States, Louisiana
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Texas
The Urology Team
Austin, Texas, United States, 78715
Baylor College of Medicine
Houston, Texas, United States, 77030
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Gerard Henry, MD Ark-LA-Tek
Principal Investigator: Anthony J. Bella, MD University of Ottawa
Principal Investigator: Edward Karpman, MD El Camino Urology Medical Group
Principal Investigator: LeRoy Jones, MD Urology San Antonio Research PA
Principal Investigator: Bryan T Kansas, MD The Urology Team
Principal Investigator: Brian Christine, MD Urology Centers of Alabama
Principal Investigator: Kevin McVary, MD SIU School of Medicine
Principal Investigator: James Hotaling, MD University of Utah
Principal Investigator: Mohit Khera, MD Baylor College of Medicine
Principal Investigator: Eugene Rhee, MD Kaiser Permanente
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01383018     History of Changes
Other Study ID Numbers: U0552
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Scientific Corporation:
Erectile Dysfunction (ED)
Penile Implant
Penile Prosthesis

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders