PROPPER Prospective Registry of Outcomes With Penile Prosthesis
This study is enrolling participants by invitation only.
Sponsor:
American Medical Systems
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01383018
First received: June 24, 2011
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Erectile Dysfunction Impotence |
Device: AMS Penile Prosthesis Devices |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER) |
Resource links provided by NLM:
Further study details as provided by American Medical Systems:
Primary Outcome Measures:
- Penile prosthesis durability and patient satisfaction [ Time Frame: 1 to 5 years post-treatment ] [ Designated as safety issue: No ]Penile prosthesis durability and patient satisfaction measured using non-validated, standardized patient questions.
- Penile prosthesis complications [ Time Frame: Implantation through up to 5 years post-treatment ] [ Designated as safety issue: No ]Penile prosthetic device complications as reported throughout post-implantation follow-up
Secondary Outcome Measures:
- Penile prosthesis effectiveness, patient satisfaction and quality of life [ Time Frame: Baseline through up to 5 years post-treatment ] [ Designated as safety issue: No ]Penile prosthesis effectiveness for erectile restoration, patient satisfaction and quality of life measurements to be performed using validated disease-specific and general HR-QoL questionnaires (per investigators' standard of care).
| Estimated Enrollment: | 1500 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
AMS penile prosthesis receipients
Men for whom an AMS penile prosthesis is recommended
|
Device: AMS Penile Prosthesis Devices
Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
Other Names:
|
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Men with ED in the United States and Canada.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383018
Locations
| United States, Alabama | |
| Urology Centers of Alabama | |
| Homewood, Alabama, United States, 35209 | |
| United States, California | |
| El Camino Urology Medical Group | |
| Mountain View, California, United States, 94040 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92154 | |
| United States, Illinois | |
| SIU School of Medicine | |
| Springfield, Illinois, United States, 62794-9664 | |
| United States, Louisiana | |
| Regional Urology | |
| Shreveport, Louisiana, United States, 71106 | |
| United States, Maryland | |
| University of Maryland School of Medicine | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Oregon | |
| Urology Specialists of Oregon - Bend | |
| Bend, Oregon, United States, 97701 | |
| United States, Texas | |
| The Urology Team | |
| Austin, Texas, United States, 78715 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Urology San Antonio Research, PA | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Canada, Ontario | |
| University of Ottawa | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
Sponsors and Collaborators
American Medical Systems
Investigators
| Principal Investigator: | Gerard Henry, MD | Regional Urology |
| Principal Investigator: | Anthony J. Bella, MD | University of Ottawa |
| Principal Investigator: | Nelson E. Bennett, Jr., MD | Lahey Clinic |
| 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: | Andrew Neeb, MD | Urology Specialists of Oregon - Bend |
| Principal Investigator: | Brian Christine, MD | Urology Centers of Alabama |
| Principal Investigator: | Tobias Kohler, MD | SIU School of Medicine |
| Principal Investigator: | William Brant, MD | University of Utah |
| Principal Investigator: | Mohit Khera, MD | Baylor College of Medicine |
| Principal Investigator: | Andrew Kramer, MD | University of Maryland |
| Principal Investigator: | Eugene Rhee, MD | Kaiser Permanente |
More Information
No publications provided
| Responsible Party: | American Medical Systems |
| ClinicalTrials.gov Identifier: | NCT01383018 History of Changes |
| Other Study ID Numbers: | ER1005 |
| Study First Received: | June 24, 2011 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by American Medical Systems:
|
Erectile Dysfunction (ED) Penile Implant Impotence Penile Prosthesis Registry |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male |
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013