PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Completed

• Conditions: Erectile Dysfunction; Impotence
• Interventions: Device: AMS Penile Prosthesis Devices

• Registration Number: NCT01383018
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study Start: 2011-06-13
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2017-11-30
• Study Completion: 2018-07-25
• Results First Submitted: 2019-12-16
• Results First Submitted QC: 2020-02-05
• Results First Posted: 2020-02-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1457

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMS penile prosthesis receipients	AMS Penile Prosthesis Devices	Men for whom an AMS penile prosthesis is recommended

Primary Outcome Measures

Name	Time	Method
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use	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 That Are Using the Device	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 Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied	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.
Number of Participants With Penile Prosthesis Overall Subject Satisfaction	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 Indicating How Often Their Use is.	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.	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 Using the Device But Not as Often as Desired	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.

Trial Locations

Locations (11)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

El Camino Urology Medical Group; 🇺🇸 Mountain View, California, United States

SIU School of Medicine; 🇺🇸 Springfield, Illinois, United States

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

Ark-LA-Tek; 🇺🇸 Bossier City, Louisiana, United States

The Urology Team; 🇺🇸 Austin, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Urology San Antonio Research, PA; 🇺🇸 San Antonio, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada