PROPPER Prospective Registry of Outcomes With Penile Prosthesis (PROPPER)

January 25, 2021 updated by: Boston Scientific Corporation

Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • University of Ottawa
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • California
      • Mountain View, California, United States, 94040
        • El Camino Urology Medical Group
      • San Diego, California, United States, 92154
        • Kaiser Permanente
    • Illinois
      • Springfield, Illinois, United States, 62794-9664
        • SIU School of Medicine
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Ark-LA-Tek
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Texas
      • Austin, Texas, United States, 78715
        • The Urology Team
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with ED in the United States and Canada.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Penile Prosthesis Overall Subject Satisfaction
Time Frame: 1 year, post-implantation
Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post-implantation
Number of Participants With Penile Prosthesis That Are Using the Device
Time Frame: 1 year, post implantation
Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
Time Frame: 1 year, post implantation
Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation
Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
Time Frame: 1 year, post implantation
Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
Time Frame: 1 year, post implantation
Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation
Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
Time Frame: 1 year, post implantation
Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied
Time Frame: 1 year, post implantation
Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
1 year, post implantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years
Time Frame: Baseline through 5 years
Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30.
Baseline through 5 years
Erection Hardness Scale Over Five Years
Time Frame: Baseline through 5 years
The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.
Baseline through 5 years
American Urology Association - Symptom Index Over Five Years
Time Frame: Baseline through 5 years
The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life.
Baseline through 5 years
UCLA Prostate Cancer Index Over Five Years
Time Frame: Baseline through 5 years
The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.
Baseline through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • 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: Eugene Rhee, MD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2011

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

July 25, 2018

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U0552

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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