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PROPPER Prospective Registry of Outcomes With Penile Prosthesis (PROPPER)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: June 24, 2011
Last updated: April 7, 2017
Last verified: April 2017
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 Intervention
Erectile Dysfunction
Device: AMS Penile Prosthesis Devices

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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).

Enrollment: 1436
Actual Study Start Date: June 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   Child, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Regional Urology
Shreveport, Louisiana, United States, 71106
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 Regional Urology
Principal Investigator: Anthony J. Bella, MD University of Ottawa
Principal Investigator: Nelson E. Bennett, Jr., MD Lahey Clinic
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: Tobias Kohler, MD SIU School of Medicine
Principal Investigator: William Brant, 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 Identifier: NCT01383018     History of Changes
Other Study ID Numbers: ER1005
Study First Received: June 24, 2011
Last Updated: April 7, 2017

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 processed this record on May 25, 2017