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Completed

NCT Number: NCT01383018

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Impotence Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Ottawa, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMS Penile Prosthesis Devices

Device

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

Other names: AMS 700, AMS Ambicor, AMS Spectra

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

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

    Time frame: Baseline through 5 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.

  2. Erection Hardness Scale Over Five Years

    Time frame: Baseline through 5 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.

  3. American Urology Association - Symptom Index Over Five Years

    Time frame: Baseline through 5 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.

  4. UCLA Prostate Cancer Index Over Five Years

    Time frame: Baseline through 5 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: PROPPER

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jun 28, 2011
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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