Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,457
- Locations
- 11
- Primary Endpoint
- Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 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 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.
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 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 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.
Secondary Outcomes
No secondary outcomes reported