Erectile DysfunctionPROPPERNCT01383018

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

An observational study of Erectile Dysfunction and Impotence, run by Boston Scientific Corporation at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Erectile Dysfunction, Impotence
What is being tested?: AMS Penile Prosthesis Devices
Type of treatment: Medical device
How many people: 1,457 participants
Where: 11 sitesin 2 countries
Study dates: 13 Jun 2011to 25 Jul 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Men with ED in the United States and Canada.

Who may be able to join

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.

Who cannot join

Men who are deemed by their physician to be not suitable for a penile implant will be excluded.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

The Urology Team
Austin, Texas, 78715
Ark-LA-Tek
Bossier City, Louisiana, 71111
Lahey Clinic
Burlington, Massachusetts, 01805
Urology Centers of Alabama
Homewood, Alabama, 35209
Baylor College of Medicine
Houston, Texas, 77030
El Camino Urology Medical Group
Mountain View, California, 94040
University of Utah
Salt Lake City, Utah, 84132
Urology San Antonio Research, PA
San Antonio, Texas, 78229
Kaiser Permanente
San Diego, California, 92154
SIU School of Medicine
Springfield, Illinois, 62794-9664

Other trials in United States

Canada1 site

University of Ottawa
Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Erectile Dysfunction, Impotence
Being tested: AMS Penile Prosthesis Devices
Keywords: Erectile Dysfunction (ED), Penile Implant, Impotence, Penile Prosthesis, Registry
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMS Penile Prosthesis DevicesDevice
Also called AMS 700, AMS Ambicor, AMS Spectra
Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Study groups in NCT01383018
Study group	Role	What they receive
AMS penile prosthesis receipients		Men for whom an AMS penile prosthesis is recommended Receives: Device: AMS Penile Prosthesis Devices

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year, post-implantation
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.
Measured: 1 year, post implantation
Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Measured: 1 year, post implantation
Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
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.
Measured: 1 year, post implantation
Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons 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.
Measured: 1 year, post implantation
Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
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.
Measured: 1 year, post implantation
Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used 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.
Measured: 1 year, post implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201125 Jul 2018

First posted28 Jun 2011 (estimated)
Study start13 Jun 2011
Primary completion30 Nov 2017
Study completion25 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,457 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01383018
Sponsor's protocol ID: U0552
Acronym: PROPPER
Status last verified: Jan 2021
First submitted: 24 Jun 2011
Last updated: 12 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
ClinicalTrials.gov ID: NCT01383018
Acronym / sponsor ID: PROPPER / U0552
Conditions: Erectile Dysfunction, Impotence
Keywords: Erectile Dysfunction (ED), Penile Implant, Impotence, Penile Prosthesis, Registry
Study type: Observational
Recruitment status: Completed
Enrolment: 1,457 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 13 Jun 2011 (actual)
Primary completion: 30 Nov 2017 (actual)
Study completion: 25 Jul 2018 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 18 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AMS penile prosthesis receipients	–	Device: AMS Penile Prosthesis DevicesMen for whom an AMS penile prosthesis is recommended

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Men with ED in the United States and Canada.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

Men who are deemed by their physician to be not suitable for a penile implant will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMS Penile Prosthesis DevicesAlso: AMS 700, AMS Ambicor, AMS SpectraNon-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.	Device	AMS penile prosthesis receipients

Primary outcome

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
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 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 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 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.
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.

Results and safety

Results posted to the registry on 18 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMS Penile Prosthesis Recipients	1,457	1,082

Primary outcome: Number of Participants With Penile Prosthesis Overall Subject Satisfaction

Time frame: 1 year, post-implantation. Count of participants. Unit: Participants

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n = 1082	AMS 700 n = 1050	AMS Ambicor n = 21	Spectra n = 11
Very Dissatisfied	34	34	0	0
Dissatisfied	37	35	2	0
Neither Satisfied nor Dissatisfied	71	68	2	1
Satisfied	297	286	5	6
Very Satisfied	643	627	12	4

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

Primary outcome: Number of Participants With Penile Prosthesis That Are Using the Device

Time frame: 1 year, post implantation. Count of participants. Unit: Participants

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n = 1082	AMS 700 n = 1050	AMS Ambicor n = 21	Spectra n = 11
Value	984	956	18	10

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

Primary outcome: Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.

Time frame: 1 year, post implantation. Count of participants. Unit: Participants

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n = 895	AMS 700 n = 867	AMS Ambicor n = 18	Spectra n = 10
Less than once per month	58	56	1	1
More than once per month	837	811	17	9

Population analysed: 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.

Primary outcome: Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.

Time frame: 1 year, post implantation. Mean (Standard Deviation). Unit: Number of times per month

Measure	All AMS Penile Prosthesis Recipients - Total Reponses n = 490	AMS 700 n = 467	AMS Ambicor n = 17	Spectra n = 6
Value	6.3 (5.5)	6.3 (5.6)	5.4 (3.3)	5.2 (4.3)

Population analysed: 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.

Adverse events

Time frame: Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMS Penile Prosthesis Receipients	36 of 1,380 (2.6%)	72 of 1,380 (5.2%)	44 of 1,380

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gerard Henry, MD principal investigator

Ark-LA-Tek

Anthony J. Bella, MD principal investigator

University of Ottawa

Edward Karpman, MD principal investigator

El Camino Urology Medical Group

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Erectile Dysfunction and Impotence, run by Boston Scientific Corporation at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Penile Prosthesis Overall Subject Satisfaction (time frame: 1 year, post-implantation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.