Penile ImplantationPROUDNCT03323645
Prosthetics Registry and Outcomes in Urology at Duke
An observational study of Penile Implantation, run by Duke University at 1 site in United States.
Trial summary
To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Implantation
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 20 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with end-stage erectile dysfunction.
Who may be able to join
- Male
- Adult (18 years of age or older)
- Inflatable or semi-rigid penile prosthesis placed
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. The study team will collect retrospective data from subjects at Duke University and Duke Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1, 1996 onward. Prospective data will only be collected from patients seeking care with Dr. Lentz in Duke Raleigh.
- Conditions
- Penile Implantation
- Keywords
- prostate cancer, erectile dysfunction, penile prosthesis
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with penile prostheses | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Dec 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: change of study structure and resource allocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile ImplantationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron C Lentz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323645
- Sponsor's protocol ID
- Pro00086257
- Acronym
- PROUD
- Status last verified
- Apr 2020
- First submitted
- 19 Oct 2017
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetics Registry and Outcomes in Urology at Duke
- ClinicalTrials.gov ID
- NCT03323645
- Acronym / sponsor ID
- PROUD / Pro00086257
- Conditions
- Penile Implantation
- Keywords
- prostate cancer, erectile dysfunction, penile prosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: change of study structure and resource allocation
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. The study team will collect retrospective data from subjects at Duke University and Duke Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1, 1996 onward. Prospective data will only be collected from patients seeking care with Dr. Lentz in Duke Raleigh.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with penile prostheses | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with end-stage erectile dysfunction.
Key inclusion criteria (3 listed)
- Male
- Adult (18 years of age or older)
- Inflatable or semi-rigid penile prosthesis placed
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses.
Time frame: up to 5 years
Results and safety
The study was stopped early (reason given: change of study structure and resource allocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Penile Implantation
Recruiting
Penile Lengthening Pre-Penile Prosthesis Implantation
Erectile Dysfunction
Active, not recruitingObservational study
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Erectile Dysfunction
Recruiting
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
Erectile Dysfunction
RecruitingObservational study
ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
Erectile Dysfunction, Gender Dysphoria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron C Lentz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Implantation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change of study structure and resource allocation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses. (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.