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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01383018
Other study ID # U0552
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2011
Est. completion date July 25, 2018

Study information

Verified date January 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1457
Est. completion date July 25, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AMS Penile Prosthesis Devices
Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Locations

Country Name City State
Canada University of Ottawa Ottawa Ontario
United States The Urology Team Austin Texas
United States Ark-LA-Tek Bossier City Louisiana
United States Lahey Clinic Burlington Massachusetts
United States Urology Centers of Alabama Homewood Alabama
United States Baylor College of Medicine Houston Texas
United States El Camino Urology Medical Group Mountain View California
United States University of Utah Salt Lake City Utah
United States Urology San Antonio Research, PA San Antonio Texas
United States Kaiser Permanente San Diego California
United States SIU School of Medicine Springfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five 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. Baseline through 5 years
Other Erection Hardness Scale Over Five 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. Baseline through 5 years
Other American Urology Association - Symptom Index Over Five 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. Baseline through 5 years
Other UCLA Prostate Cancer Index Over Five 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. Baseline through 5 years
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. 1 year, post-implantation
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. 1 year, post implantation
Primary 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
Primary 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
Primary 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
Primary 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
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 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
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