PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Erectile Dysfunction Clinical Trial

— PROPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383018
• Other study ID #: U0552
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence

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