Peyronie DiseaseFRAPEYQUESTNCT05768867
French Translation and Validation of the PEYronie's Disease QUESTionnaire
An observational study of Peyronie Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- FRAnçaise du PEYronie's Disease QUESTionnaire
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2023to 22 May 2023
- 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: Patients with Peyronie's Disease
Who may be able to join
- Adult patient with Peyronie's Disease clinically diagnosed during a consultation, with palpation of at least one plaque
Who cannot join
- Patient refusing to participate
- Patient with difficulties in understanding the French language.
- Protected persons referred to in articles L.1121-6 to L.1121-8 of the public health code
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.
- Conditions
- Peyronie Disease
- Being tested
- FRAnçaise du PEYronie's Disease QUESTionnaire
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAnçaise du PEYronie's Disease QUESTionnaireOther
Complete an online FRAnçaise du PEYronie's Disease QUESTionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of responses
Response rate to the online questionnaire.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start6 Mar 2023
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Huyghe, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768867
- Sponsor's protocol ID
- RC31/23/0012
- Other IDs
- 2023-A00219-36
- Acronym
- FRAPEYQUEST
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Translation and Validation of the PEYronie's Disease QUESTionnaire
- ClinicalTrials.gov ID
- NCT05768867
- Acronym / sponsor ID
- FRAPEYQUEST / RC31/23/0012
- Conditions
- Peyronie Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 14 Mar 2023 (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.
This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Peyronie's Disease
Key inclusion criteria (1 listed)
- Adult patient with Peyronie's Disease clinically diagnosed during a consultation, with palpation of at least one plaque
Key exclusion criteria (3 listed)
- Patient refusing to participate
- Patient with difficulties in understanding the French language.
- Protected persons referred to in articles L.1121-6 to L.1121-8 of the public health code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAnçaise du PEYronie's Disease QUESTionnaireComplete an online FRAnçaise du PEYronie's Disease QUESTionnaire | Other | – |
Primary outcome
Rate of responses
Time frame: Day 0
Response rate to the online questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Eric Huyghe, MD principal investigator
University Hospital, Toulouse
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 Peyronie Disease, run by University Hospital, Toulouse at 1 site in France.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Aug 2024. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of responses (time frame: Day 0). 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 27 Aug 2024.