PROPPER Prospective Registry of Outcomes With Penile Prosthesis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01383018
First received: June 24, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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
Impotence
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 American Medical Systems:

Primary Outcome Measures:
  • Penile prosthesis durability and patient satisfaction [ Time Frame: 1 to 5 years post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1500
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men with ED in the United States and Canada.

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.

  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 ClinicalTrials.gov identifier: NCT01383018

Locations
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
American Medical Systems
Investigators
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

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT01383018     History of Changes
Other Study ID Numbers: ER1005
Study First Received: June 24, 2011
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by American Medical Systems:
Erectile Dysfunction (ED)
Penile Implant
Impotence
Penile Prosthesis
Registry

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

ClinicalTrials.gov processed this record on July 23, 2014