PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Overview

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.

Full Title of Study: “Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2017

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.

Interventions

  • Device: AMS Penile Prosthesis Devices
    • Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Arms, Groups and Cohorts

  • AMS penile prosthesis receipients
    • Men for whom an AMS penile prosthesis is recommended

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Scientific Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gerard Henry, MD, Principal Investigator, Ark-LA-Tek
    • Anthony J. Bella, MD, Principal Investigator, University of Ottawa
    • Edward Karpman, MD, Principal Investigator, El Camino Urology Medical Group
    • LeRoy Jones, MD, Principal Investigator, Urology San Antonio Research PA
    • Bryan T Kansas, MD, Principal Investigator, The Urology Team
    • Brian Christine, MD, Principal Investigator, Urology Centers of Alabama
    • Kevin McVary, MD, Principal Investigator, SIU School of Medicine
    • James Hotaling, MD, Principal Investigator, University of Utah
    • Mohit Khera, MD, Principal Investigator, Baylor College of Medicine
    • Eugene Rhee, MD, Principal Investigator, Kaiser Permanente

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