PROPPER Prospective Registry of Outcomes With Penile Prosthesis
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
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Volunteers
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.
Trial design
1,457 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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