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.
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
1,457
Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
Urology Centers of Alabama
Homewood, Alabama, United States
El Camino Urology Medical Group
Mountain View, California, United States
Kaiser Permanente
San Diego, California, United States
Number of Participants With Penile Prosthesis Overall Subject Satisfaction
Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time frame: 1 year, post-implantation
Number of Participants With Penile Prosthesis That Are Using the Device
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.
Time frame: 1 year, post implantation
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time frame: 1 year, post implantation
Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
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.
Time frame: 1 year, post implantation
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
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.
Time frame: 1 year, post implantation
Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
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.
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SIU School of Medicine
Springfield, Illinois, United States
Ark-LA-Tek
Bossier City, Louisiana, United States
Lahey Clinic
Burlington, Massachusetts, 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
...and 1 more locations
Time frame: 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
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.
Time frame: 1 year, post implantation