Clinical trial NCT01383018: PROPPER Prospective Registry of Outcomes With Penile Prosthesis
Official title: Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Impotence
Keywords: Erectile Dysfunction (ED)
Penile Implant
Impotence
Penile Prosthesis
Registry
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 1457
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with ED in the United States and Canada.

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.

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 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.

Primary outcomes:
measure: Number of Participants With Penile Prosthesis Overall Subject Satisfaction
timeFrame: 1 year, post-implantation
measure: Number of Participants With Penile Prosthesis That Are Using the Device
timeFrame: 1 year, post implantation
measure: Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
timeFrame: 1 year, post implantation
measure: Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
timeFrame: 1 year, post implantation
measure: Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
timeFrame: 1 year, post implantation
measure: Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
timeFrame: 1 year, post implantation
measure: Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied
timeFrame: 1 year, post implantation
Secondary outcomes:
Other outcomes:
measure: Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years
timeFrame: Baseline through 5 years
measure: Erection Hardness Scale Over Five Years
timeFrame: Baseline through 5 years
measure: American Urology Association - Symptom Index Over Five Years
timeFrame: Baseline through 5 years
measure: UCLA Prostate Cancer Index Over Five Years
timeFrame: Baseline through 5 years
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Mountain View
country: United States
facility: El Camino Urology Medical Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Bossier City
country: United States
facility: Ark-LA-Tek
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Austin
country: United States
facility: The Urology Team
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: Ark-LA-Tek
name: Gerard Henry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Anthony J. Bella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: El Camino Urology Medical Group
name: Edward Karpman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology San Antonio Research PA
name: LeRoy Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Urology Team
name: Bryan T Kansas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology Centers of Alabama
name: Brian Christine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SIU School of Medicine
name: Kevin McVary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: James Hotaling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Mohit Khera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Eugene Rhee, MD
role: PRINCIPAL_INVESTIGATOR
References: