PROPPER Prospective Registry of Outcomes With Penile Prosthesis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01383018

Acronym

PROPPER

Enrollment

1457

Registered

2011-06-28

Start date

2011-06-13

Completion date

2018-07-25

Last updated

2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Impotence

Keywords

Erectile Dysfunction (ED), Penile Implant, Impotence, Penile Prosthesis, Registry

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.

Interventions

DEVICEAMS Penile Prosthesis Devices

Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied	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 That Are Using the Device Indicating How Often Their Use is.	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.	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 That Were Not Using the Device, Reasons for Non-use	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 Using the Device But Not as Often as Desired	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.
Number of Participants With Penile Prosthesis Overall Subject Satisfaction	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	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.

Other

Measure	Time frame	Description
Erection Hardness Scale Over Five Years	Baseline through 5 years	The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.
American Urology Association - Symptom Index Over Five Years	Baseline through 5 years	The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from non-missing items. The lower score means a better quality of life.
UCLA Prostate Cancer Index Over Five Years	Baseline through 5 years	The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years	Baseline through 5 years	Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30.

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
AMS Penile Prosthesis Recipients Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.	1,380
Total	1,380

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	14
Overall Study	Death	10
Overall Study	Lost to Follow-up	5
Overall Study	Missed Visit	247
Overall Study	Patient moved away from site	1
Overall Study	Physician Decision	5
Overall Study	Site closed early-not compliance related	7
Overall Study	Subject Incarcerated	1
Overall Study	Subject not implanted	76
Overall Study	Withdrawal by Subject	9

Baseline characteristics

Characteristic	AMS Penile Prosthesis Recipients
Age, Continuous	63.8 years STANDARD_DEVIATION 9.7
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1303 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Primary ED etiology Cardiovascular disease	251 Participants
Primary ED etiology Diabetes	283 Participants
Primary ED etiology Other	335 Participants
Primary ED etiology Peyronies disease	123 Participants
Primary ED etiology Priaprism	19 Participants
Primary ED etiology Radical prostatectomy (RP)	369 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants
Race (NIH/OMB) Asian	15 Participants
Race (NIH/OMB) Black or African American	187 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants
Race (NIH/OMB) White	1152 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	1380 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	44 / 1,380
other Total, other adverse events	72 / 1,380
serious Total, serious adverse events	36 / 1,380

Outcome results

Primary

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.

Time frame: 1 year, post-implantation

Population: Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
All AMS Penile Prosthesis Recipients - Total Reponses	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Satisfied	297 Participants
All AMS Penile Prosthesis Recipients - Total Reponses	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Dissatisfied	37 Participants
All AMS Penile Prosthesis Recipients - Total Reponses	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Satisfied	643 Participants
All AMS Penile Prosthesis Recipients - Total Reponses	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Neither Satisfied nor Dissatisfied	71 Participants
All AMS Penile Prosthesis Recipients - Total Reponses	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Dissatisfied	34 Participants
AMS 700	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Neither Satisfied nor Dissatisfied	68 Participants
AMS 700	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Satisfied	286 Participants
AMS 700	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Satisfied	627 Participants
AMS 700	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Dissatisfied	35 Participants
AMS 700	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Dissatisfied	34 Participants
AMS Ambicor	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Neither Satisfied nor Dissatisfied	2 Participants
AMS Ambicor	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Dissatisfied	0 Participants
AMS Ambicor	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Dissatisfied	2 Participants
AMS Ambicor	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Satisfied	5 Participants
AMS Ambicor	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Satisfied	12 Participants
Spectra	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Satisfied	6 Participants
Spectra	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Dissatisfied	0 Participants
Spectra	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Dissatisfied	0 Participants
Spectra	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Neither Satisfied nor Dissatisfied	1 Participants
Spectra	Number of Participants With Penile Prosthesis Overall Subject Satisfaction	Very Satisfied	4 Participants

Primary

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.