NCT01383018

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 18, 2020

Completed
Last Updated

February 12, 2021

Status Verified

January 1, 2021

Enrollment Period

6.5 years

First QC Date

June 24, 2011

Results QC Date

December 16, 2019

Last Update Submit

January 25, 2021

Conditions

Erectile DysfunctionImpotence

Keywords

Erectile Dysfunction (ED)Penile ImplantImpotencePenile ProsthesisRegistry

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    1 year, post implantation

Other Outcomes (4)

  • Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years

    Baseline through 5 years

  • Erection Hardness Scale Over Five Years

    Baseline through 5 years

  • American Urology Association - Symptom Index Over Five Years

    Baseline through 5 years

  • +1 more other outcomes

Study Arms (1)

AMS penile prosthesis receipients

Men for whom an AMS penile prosthesis is recommended

Device: AMS Penile Prosthesis Devices

Interventions

AMS Penile Prosthesis DevicesDEVICE

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

Also known as: AMS 700, AMS Ambicor, AMS Spectra
AMS penile prosthesis receipients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with ED in the United States and Canada.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

El Camino Urology Medical Group

Mountain View, California, 94040, United States

Location

Kaiser Permanente

San Diego, California, 92154, United States

Location

SIU School of Medicine

Springfield, Illinois, 62794-9664, United States

Location

Ark-LA-Tek

Bossier City, Louisiana, 71111, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

The Urology Team

Austin, Texas, 78715, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Urology San Antonio Research, PA

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Ottawa

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Results Point of Contact

Title
Amanda Vail, Clinical Project Manager
Organization
Boston Scientific
amanda.vail@bsci.com
612-749-5366

Study Officials

  • Gerard Henry, MD

    Ark-LA-Tek

    PRINCIPAL INVESTIGATOR

  • Anthony J. Bella, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

  • Edward Karpman, MD

    El Camino Urology Medical Group

    PRINCIPAL INVESTIGATOR

  • LeRoy Jones, MD

    Urology San Antonio Research PA

    PRINCIPAL INVESTIGATOR

  • Bryan T Kansas, MD

    The Urology Team

    PRINCIPAL INVESTIGATOR

  • Brian Christine, MD

    Urology Centers of Alabama

    PRINCIPAL INVESTIGATOR

  • Kevin McVary, MD

    SIU School of Medicine

    PRINCIPAL INVESTIGATOR

  • James Hotaling, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Mohit Khera, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Eugene Rhee, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 28, 2011

Study Start

June 13, 2011

Primary Completion

November 30, 2017

Study Completion

July 25, 2018

Last Updated

February 12, 2021

Results First Posted

February 18, 2020

Record last verified: 2021-01

Locations

US(10)CA(1)