PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction, Impotence

Intervention / Treatment
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* Device: AMS Penile Prosthesis Devices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AMS penile prosthesis receipients<br>Men for whom an AMS penile prosthesis is recommended | Device: AMS Penile Prosthesis Devices<br>* Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.<br>* Other names: AMS Spectra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 year, post implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction (ED), Penile Implant, Impotence, Penile Prosthesis, Registry