CompletedNot Applicable

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

United States1,457 participantsStarted 2011-06-13

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Penile Prosthesis Overall Subject Satisfaction

Timeframe: 1 year, post-implantation

Number of Participants With Penile Prosthesis That Are Using the Device

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.

Timeframe: 1 year, post implantation

Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired

Timeframe: 1 year, post implantation

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

Trial details

NCT IDNCT01383018

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-11-30

Results submitted2019-12-16

View on ClinicalTrials.gov More Erectile Dysfunction trials

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Penile Prosthesis Overall Subject Satisfaction

Timeframe: 1 year, post-implantation

Number of Participants With Penile Prosthesis That Are Using the Device

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.

Timeframe: 1 year, post implantation

Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use

Timeframe: 1 year, post implantation

Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired

Timeframe: 1 year, post implantation

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