PROPPER Prospective Registry of Outcomes With Penile Prosthesis (NCT01383018) | Clinical Trial Compass
CompletedNot Applicable
PROPPER Prospective Registry of Outcomes With Penile Prosthesis
United States, Canada1,457 participantsStarted 2011-06-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Penile Prosthesis Overall Subject Satisfaction
Timeframe: 1 year, post-implantation
2
Number of Participants With Penile Prosthesis That Are Using the Device
Timeframe: 1 year, post implantation
3
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
Timeframe: 1 year, post implantation
4
Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
Timeframe: 1 year, post implantation
5
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
Timeframe: 1 year, post implantation
6
Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
Timeframe: 1 year, post implantation
7
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied