N/A
Completed N=1,457
PROPPER Prospective Registry of Outcomes With Penile Prosthesis
Erectile Dysfunction · Impotence
Source: ClinicalTrials.gov NCT01383018 ↗
Enrolled (actual)
1,457
Serious AEs
2.6%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Penile Prosthesis Overall Subject Satisfaction — 34; 34; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Penile Prosthesis Overall Subject Satisfaction |
34; 34; 0; 0; 37; 35 | — |
| PRIMARY Number of Participants With Penile Prosthesis That Are Using the Device |
984; 956; 18; 10 | — |
| PRIMARY Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. |
58; 56; 1; 1; 837; 811 | — |
| PRIMARY Number of Times Per Month Participants With Penile Prosthesis Are Using the Device. |
6.3; 6.3; 5.4; 5.2 | — |
| PRIMARY Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use |
8; 7; 1; 0; 9; 8 | — |
| PRIMARY Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired |
109; 96; 9; 4 | — |
| PRIMARY Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied |
4; 4; 0; 0; 9; 8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01383018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.