Trial Outcomes & Findings for PROPPER Prospective Registry of Outcomes With Penile Prosthesis (NCT NCT01383018)

NCT ID: NCT01383018

Last Updated: 2021-02-12

Results Overview

Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

• Recruitment status: COMPLETED
• Target enrollment: 1457 participants
• Primary outcome timeframe: 1 year, post-implantation
• Results posted on: 2021-02-12

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	1457
Overall Study COMPLETED	1082
Overall Study NOT COMPLETED	375

Reasons for withdrawal

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

Baseline Characteristics

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Baseline characteristics by cohort

Measure	AMS Penile Prosthesis Recipients n=1380 Participants 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.
Age, Continuous	63.8 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1380 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1303 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	187 Participants n=5 Participants
Race (NIH/OMB) White	1152 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Primary ED etiology Radical prostatectomy (RP)	369 Participants n=5 Participants
Primary ED etiology Diabetes	283 Participants n=5 Participants
Primary ED etiology Cardiovascular disease	251 Participants n=5 Participants
Primary ED etiology Peyronies disease	123 Participants n=5 Participants
Primary ED etiology Priaprism	19 Participants n=5 Participants
Primary ED etiology Other	335 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year, post-implantation

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

Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1082 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=1050 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=21 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=11 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis Overall Subject Satisfaction Dissatisfied	37 Participants	35 Participants	2 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis Overall Subject Satisfaction Neither Satisfied nor Dissatisfied	71 Participants	68 Participants	2 Participants	1 Participants	—	—
Number of Participants With Penile Prosthesis Overall Subject Satisfaction Satisfied	297 Participants	286 Participants	5 Participants	6 Participants	—	—
Number of Participants With Penile Prosthesis Overall Subject Satisfaction Very Dissatisfied	34 Participants	34 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis Overall Subject Satisfaction Very Satisfied	643 Participants	627 Participants	12 Participants	4 Participants	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

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

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1082 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=1050 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=21 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=11 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis That Are Using the Device	984 Participants	956 Participants	18 Participants	10 Participants	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

Population: Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who answered that they were using the device and responded to how often they were using it.

Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=895 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=867 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=18 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=10 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. More than once per month	837 Participants	811 Participants	17 Participants	9 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. Less than once per month	58 Participants	56 Participants	1 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

Population: Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who hand answered that they were using the device and responded to how many times per month they were using it.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=490 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=467 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=17 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=6 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.	6.3 Number of times per month Standard Deviation 5.5	6.3 Number of times per month Standard Deviation 5.6	5.4 Number of times per month Standard Deviation 3.3	5.2 Number of times per month Standard Deviation 4.3	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

Population: Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who had answered that they were not using the device and responded to the reason for non-use.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=89 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=87 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=2 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Partner disinterest	9 Participants	8 Participants	1 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Device problem	8 Participants	8 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Loss of partner	8 Participants	7 Participants	1 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Device dissatisfaction	17 Participants	17 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Health decline	13 Participants	13 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Other reason	34 Participants	34 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

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

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1082 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=1050 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=21 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=11 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired	109 Participants	96 Participants	9 Participants	4 Participants	—	—

PRIMARY outcome

Timeframe: 1 year, post implantation

Population: Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit and responded that they were using the device less than desired or dissatisfied.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=133 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=117 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=11 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=5 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Loss of partner	4 Participants	4 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Partner disinterest	9 Participants	8 Participants	0 Participants	1 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Device problem	6 Participants	5 Participants	1 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Device dissatisfaction	14 Participants	14 Participants	0 Participants	0 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Other reason	87 Participants	74 Participants	9 Participants	4 Participants	—	—
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Health decline	13 Participants	12 Participants	1 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 5 years

Population: Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1194 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years Baseline	6.4 score on a scale Standard Deviation 5.2	—	—	—	—	—
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years 4 year	20.6 score on a scale Standard Deviation 6.8	—	—	—	—	—
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years 5 year	21.2 score on a scale Standard Deviation 6.2	—	—	—	—	—
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years 1 year	20.6 score on a scale Standard Deviation 6.4	—	—	—	—	—
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years 2 year	20.4 score on a scale Standard Deviation 6.6	—	—	—	—	—
Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years 3 year	21.2 score on a scale Standard Deviation 6.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 5 years

Population: Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1209 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
Erection Hardness Scale Over Five Years Baseline	1.0 score on a scale Standard Deviation 1.1	—	—	—	—	—
Erection Hardness Scale Over Five Years 2 year	3.5 score on a scale Standard Deviation 1.0	—	—	—	—	—
Erection Hardness Scale Over Five Years 3 year	3.5 score on a scale Standard Deviation 0.9	—	—	—	—	—
Erection Hardness Scale Over Five Years 4 year	3.5 score on a scale Standard Deviation 1.0	—	—	—	—	—
Erection Hardness Scale Over Five Years 1 year	3.4 score on a scale Standard Deviation 1.0	—	—	—	—	—
Erection Hardness Scale Over Five Years 5 year	3.5 score on a scale Standard Deviation 0.9	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 5 years

Population: Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=1114 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother Urinary bother measure	UCLA-PCI Bowel Bother Bowel bother measure
American Urology Association - Symptom Index Over Five Years Baseline	9.0 score on a scale Standard Deviation 6.9	—	—	—	—	—
American Urology Association - Symptom Index Over Five Years 1 year	7.9 score on a scale Standard Deviation 6.6	—	—	—	—	—
American Urology Association - Symptom Index Over Five Years 5 year	8.1 score on a scale Standard Deviation 5.7	—	—	—	—	—
American Urology Association - Symptom Index Over Five Years 2 year	8.8 score on a scale Standard Deviation 7.0	—	—	—	—	—
American Urology Association - Symptom Index Over Five Years 3 year	8.2 score on a scale Standard Deviation 6.5	—	—	—	—	—
American Urology Association - Symptom Index Over Five Years 4 year	8.1 score on a scale Standard Deviation 6.3	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 5 years

Population: Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

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.

Outcome measures

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n=833 Participants Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700 n=814 Participants AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor n=804 Participants AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra n=820 Participants Spectra, only Men for whom a Spectra penile prosthesis was recommended	UCLA-PCI Urinary Bother n=812 Participants Urinary bother measure	UCLA-PCI Bowel Bother n=802 Participants Bowel bother measure
UCLA Prostate Cancer Index Over Five Years Baseline	21.5 score on a scale Standard Deviation 16.9	79.9 score on a scale Standard Deviation 24.3	85.0 score on a scale Standard Deviation 15.5	10.8 score on a scale Standard Deviation 22.8	76.7 score on a scale Standard Deviation 31.6	85.5 score on a scale Standard Deviation 24.1
UCLA Prostate Cancer Index Over Five Years 1 year	70.9 score on a scale Standard Deviation 20.9	82.6 score on a scale Standard Deviation 20.9	88.4 score on a scale Standard Deviation 14.3	77.3 score on a scale Standard Deviation 32.7	81.1 score on a scale Standard Deviation 26.6	87.3 score on a scale Standard Deviation 22.3
UCLA Prostate Cancer Index Over Five Years 2 year	70.0 score on a scale Standard Deviation 21.6	83.4 score on a scale Standard Deviation 20.8	87.8 score on a scale Standard Deviation 15.9	77.9 score on a scale Standard Deviation 33.2	80.5 score on a scale Standard Deviation 27.3	86.5 score on a scale Standard Deviation 23.5
UCLA Prostate Cancer Index Over Five Years 3 year	71.7 score on a scale Standard Deviation 20.8	83.8 score on a scale Standard Deviation 21.2	87.5 score on a scale Standard Deviation 17.1	78.8 score on a scale Standard Deviation 32.2	79.0 score on a scale Standard Deviation 28.3	86.8 score on a scale Standard Deviation 23.7
UCLA Prostate Cancer Index Over Five Years 4 year	70.3 score on a scale Standard Deviation 22.2	86.0 score on a scale Standard Deviation 19.6	87.8 score on a scale Standard Deviation 17.3	80.7 score on a scale Standard Deviation 31.9	79.9 score on a scale Standard Deviation 27.3	86.6 score on a scale Standard Deviation 24.3
UCLA Prostate Cancer Index Over Five Years 5 year	71.2 score on a scale Standard Deviation 21.3	85.9 score on a scale Standard Deviation 21.5	86.7 score on a scale Standard Deviation 19.3	83.1 score on a scale Standard Deviation 29.4	80.5 score on a scale Standard Deviation 28.3	84.8 score on a scale Standard Deviation 26.0

Adverse Events

AMS Penile Prosthesis Receipients

Serious events: 36 serious events

Other events: 72 other events

Deaths: 44 deaths

Serious adverse events

Measure	AMS Penile Prosthesis Receipients n=1380 participants at risk 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.
Infections and infestations Device Infection	0.80% 11/1380 • Number of events 13 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Erosion	0.43% 6/1380 • Number of events 6 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Reservoir Herniation	0.22% 3/1380 • Number of events 3 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Abscess	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Hematoma	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Pain/Discomfort	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Renal and urinary disorders Urinary Retention	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Vascular disorders Cardiac Event - Non-specific	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Cellulitis	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Cylinder Crossover	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Device Cylinder Aneruysm/Bulge	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Edema - Scrotal	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Extrusion	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort - Penile	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Perforation - Other	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Reproductive system and breast disorders Peyronie's Disease	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Proximal Corporal Perforation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Vascular disorders Pulmonary Embolus	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Urethral Obstruction	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Would Dehiscence	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Cardiac disorders Other - Substernal Chest Pain	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Respiratory, thoracic and mediastinal disorders Other - Decreased Oxygen Saturation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.

Other adverse events

Measure	AMS Penile Prosthesis Receipients n=1380 participants at risk 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.
Injury, poisoning and procedural complications Hematoma	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Urinary Retention	0.22% 3/1380 • Number of events 3 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Device Infection	0.36% 5/1380 • Number of events 5 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Erosion	0.36% 5/1380 • Number of events 5 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Reservoir Herniation	0.29% 4/1380 • Number of events 4 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Superficial Wound Infection	0.29% 4/1380 • Number of events 4 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Device Cylinder Aneurysm/Bulge	0.22% 3/1380 • Number of events 3 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Migration (pump)	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Urethral Trauma	0.22% 3/1380 • Number of events 3 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Extrusion	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Malposition	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort - Groin	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Reproductive system and breast disorders Priapism	0.07% 1/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Adhesion of the Pump/Scrotum	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Immune system disorders Allergic reaction/Hypersensitivity Reaction	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Auto Inflation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Renal and urinary disorders Bladder Neck Obstruction	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Cellulitis	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Device Placement Failure	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Edema - Penile	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Investigations Fever	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Fibrosis	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Fibrous Capsule Formation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Reproductive system and breast disorders Hematospermia	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Renal and urinary disorders Hematuria	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Incorrect Size - Cylinders too Large	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Vascular disorders Increased Blood Loss	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Musculoskeletal and connective tissue disorders Inguinal Hernia Formation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort - Other	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort - Penile	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort With Erections	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Patient Dissatisfaction	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Perforation - Other	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Reproductive system and breast disorders Peyronie's Disease	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Proximal Corporal Perforation	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Urinary Tract Infection - UTI	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Renal and urinary disorders Urinary Retention	0.22% 3/1380 • Number of events 3 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Musculoskeletal and connective tissue disorders Pain/Discomfort	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Pain/Discomfort	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Migration (Pump)	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Migration (Pump)	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Pain/Discomfort - Groin	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Pain/Discomfort - Testicular	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Pain/Discomfort - Testicular	0.14% 2/1380 • Number of events 2 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Other - Buckling of left cylinder led to left downward curvature	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Reproductive system and breast disorders Other - Painful mass in right hemiscrotum	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Other - Left distal tip migration with pain at tip of penis with intercourse	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Other - Right cylinder protruding	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
General disorders Other - Pinching sensation around the resevoirs	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Other - Change in curvature of penis (increase in curvature)	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Other - Proximal cross over during IPP surgery	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Infections and infestations Other - Incisional drainage	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Product Issues Other - Bilateral corporal aneurysm	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Injury, poisoning and procedural complications Other - Proximal crossover	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.
Skin and subcutaneous tissue disorders Other - Slight separation of penoscrotal wound	0.07% 1/1380 • Number of events 1 • Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up. All device and/or procedure related events were collected for this study.

Additional Information

Amanda Vail, Clinical Project Manager

Boston Scientific

Phone: 612-749-5366

Email: amanda.vail@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER