Peyronie DiseaseTurkish PDQNCT06621420
Peyronie Disease Questionnaire (PDQ): Turkish Validation
An observational study of Peyronie Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the present study is to translate into the Turkish and a perform a validation of the Turkish version of a PDQ and to ensure the use of Turkish validation of the PDQ in clinical use and studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Peyronie Disease
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Mar 2025
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men living in the Marmara region whose native language is Turkish
Who may be able to join
- adult patients (≥18 years),
- men,
- diagnosis of PD, except those who have previously received invasive treatment
Who cannot join
- had an insufficient level of Turkish to write and/or understand the methodology of the questionnaire and follow the guidelines described,
- had previously received an invasive treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study is to translate into the Turkish and a perform a validation of the Turkish version of a PDQ and to ensure the use of Turkish validation of the PDQ in clinical use and studies.
Read the detailed description
The Peyronie Disease Questionnaire (PDQ) The PDQ is a 15-item, self-administered, disease-specific, and multidimensional printed format instrument developed to quantify the psychosexual symptoms of PD. The PDQ includes three scales: ;psychological and physical symptoms; (6 items) ;penile pain; (3 items), and ;symptom bother; (4 scored items and 2 yes/no questions). The ;psychological and physical symptom; domain has a 5-level Likert scale ranging from ;none; to ;very severe.; Patients must complete items on the ;penile pain; domain thinking about the last 24 h, and a numeric scale ranging from 0 to 10 was used to evaluate its severity. The;symptom bother; domain has a 5-level Likert scale (not at all bothered; a little bit bothered, ;moderately bothered,very ;and extremely bothered). The sum of all responses is calculated and given separately for each domain, as long as a total PDQ score is not intended. Higher domain scores indicate a greater negative impact, being the score range from 0 to 24 for ;psychological and physical symptom; from 0 to 30 for ;penile pain and from 0 to 16 for ;symptom bother
The PDQ translation procedure followed a structured method to ensure reliability. The translation method included the following steps: 1. Translation of the original questionnaire to Spanish by two independent professional translators. 2. Merging both translated versions by the research team. 3. Back translation of the merged version by two native English professional translators. 4. Review of the different back-translated English versions with the original questionnaire by the research team. 5. Revising the conceptual equivalence with the original, performed by both the translators and the researchers. 6. Testing the translated questionnaire in a pilot group of 30 patients. 7. Results analysis of the pilot test and completion of translation by the research team. 8. Final editions of the questionnaire. 9. Final report of the researchers.
This study included a total of 60 patients with a diagnosis of PD excluding those who had previously received invasive treatment. Males over 18 years of age and patients diagnosed with Peyronie disease who had not undergone surgery were included in the study.
The test-retest reliability of the PDQ-I and the internal consistency of its subscales will be assessed. Intraclass correlation coefficients (ICC) will be calculated to assess the degree of association between the PDQ subscale scores. Paired Student t-tests will be used to assess whether there are statistically significant score changes between T1 and T2. Internal consistency reliability will be assessed by calculating Cronbachs alpha for each of the three PDQ subscales.
- Conditions
- Peyronie Disease
- Keywords
- Peyronie, Questionnaire, validation
- Medical subject headings
- Penile Induration
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and usability of the Turkish translation of the PDQ
The scores given by the patients according to the previously proven PDQ scoring will be compared statistically. As a result of this comparison, it will be investigated how consistent and reliable the translation is. The measurement tool in this study is the Peyronie disease questionnaire. The PDQ is a 15-item, self-administered, disease-specific, and multidimensional printed format instrument developed to quantify the psychosexual symptoms of PD. The PDQ includes three scales: "psychological and physical symptoms" (6 items), "penile pain" (3 items), and "symptom bother" (4 scored items and 2 yes/no questions). The "psychological and physical symptom" domain has a 5-level Likert scale ranging from "none" to "very severe." Patients must complete items on the "penile pain" domain thinking about the last 24 h, and a numeric scale ranging from 0 to 10 was used to evaluate its severity. The "symptom bother" domain has a 5-level Likert scale ("not at all bothered," "a little bit bothered,").
Measured: From September 2024 to April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Sep 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Citamak, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621420
- Sponsor's protocol ID
- 2024-8/314
- Acronym
- Turkish PDQ
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hellstrom WJ, Feldman R, Rosen RC, Smith T, Kaufman G, Tursi J. Bother and distress associated with Peyronie's disease: validation of the Peyronie's disease questionnaire. J Urol. 2013 Aug;190(2):627-34. doi: 10.1016/j.juro.2013.01.090. Epub 2013 Jan 31.
PubMed 23376705Garcia-Gomez B, Martinez-Salamanca JI, Sarquella-Geli J, Justo-Quintas J, Garcia-Rojo E, Fernandez-Pascual E, Ruiz-Castane E, Romero-Otero J. Correction: Peyronie's Disease Questionnaire (PDQ): Spanish translation and validation. Int J Impot Res. 2024 Feb;36(1):102. doi: 10.1038/s41443-023-00734-0. No abstract available.
PubMed 37464022Traunero F, Di Grazia M, Ongaro L, Rizzo M, Cocci A, Verze P, Zucchi A, Cai T, Salame L, Garaffa G, Trombetta C, Liguori G. Validation of the Italian version of the Peyronie's Disease Questionnaire (PDQ). Int J Impot Res. 2024 Sep;36(6):588-591. doi: 10.1038/s41443-023-00792-4. Epub 2023 Nov 17.
PubMed 37978202Citamak B, Dogan C, Koroglu MS, Baser A, Ozkaptan O, Cubuk A. Turkish Translation, Validation, and Clinical Utilization of the Peyronie's Disease Questionnaire. Arch Esp Urol. 2026 Aug;79(7):1115-1122. doi: 10.56434/j.arch.esp.urol.aeu007.
PubMed 42684278
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peyronie Disease Questionnaire (PDQ): Turkish Validation
- ClinicalTrials.gov ID
- NCT06621420
- Acronym / sponsor ID
- Turkish PDQ / 2024-8/314
- Conditions
- Peyronie Disease
- Keywords
- Peyronie, Questionnaire, validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
The purpose of the present study is to translate into the Turkish and a perform a validation of the Turkish version of a PDQ and to ensure the use of Turkish validation of the PDQ in clinical use and studies.
Detailed description
The Peyronie Disease Questionnaire (PDQ) The PDQ is a 15-item, self-administered, disease-specific, and multidimensional printed format instrument developed to quantify the psychosexual symptoms of PD. The PDQ includes three scales: ;psychological and physical symptoms; (6 items) ;penile pain; (3 items), and ;symptom bother; (4 scored items and 2 yes/no questions). The ;psychological and physical symptom; domain has a 5-level Likert scale ranging from ;none; to ;very severe.; Patients must complete items on the ;penile pain; domain thinking about the last 24 h, and a numeric scale ranging from 0 to 10 was used to evaluate its severity. The;symptom bother; domain has a 5-level Likert scale (not at all bothered; a little bit bothered, ;moderately bothered,very ;and extremely bothered). The sum of all responses is calculated and given separately for each domain, as long as a total PDQ score is not intended. Higher domain scores indicate a greater negative impact, being the score range from 0 to 24 for ;psychological and physical symptom; from 0 to 30 for ;penile pain and from 0 to 16 for ;symptom bother
The PDQ translation procedure followed a structured method to ensure reliability. The translation method included the following steps: 1. Translation of the original questionnaire to Spanish by two independent professional translators. 2. Merging both translated versions by the research team. 3. Back translation of the merged version by two native English professional translators. 4. Review of the different back-translated English versions with the original questionnaire by the research team. 5. Revising the conceptual equivalence with the original, performed by both the translators and the researchers. 6. Testing the translated questionnaire in a pilot group of 30 patients. 7. Results analysis of the pilot test and completion of translation by the research team. 8. Final editions of the questionnaire. 9. Final report of the researchers.
This study included a total of 60 patients with a diagnosis of PD excluding those who had previously received invasive treatment. Males over 18 years of age and patients diagnosed with Peyronie disease who had not undergone surgery were included in the study.
The test-retest reliability of the PDQ-I and the internal consistency of its subscales will be assessed. Intraclass correlation coefficients (ICC) will be calculated to assess the degree of association between the PDQ subscale scores. Paired Student t-tests will be used to assess whether there are statistically significant score changes between T1 and T2. Internal consistency reliability will be assessed by calculating Cronbachs alpha for each of the three PDQ subscales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men living in the Marmara region whose native language is Turkish
Key inclusion criteria (3 listed)
- adult patients (≥18 years),
- men,
- diagnosis of PD, except those who have previously received invasive treatment
Key exclusion criteria (2 listed)
- had an insufficient level of Turkish to write and/or understand the methodology of the questionnaire and follow the guidelines described,
- had previously received an invasive treatment
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
Reliability and usability of the Turkish translation of the PDQ
Time frame: From September 2024 to April 2025
The scores given by the patients according to the previously proven PDQ scoring will be compared statistically. As a result of this comparison, it will be investigated how consistent and reliable the translation is. The measurement tool in this study is the Peyronie disease questionnaire. The PDQ is a 15-item, self-administered, disease-specific, and multidimensional printed format instrument developed to quantify the psychosexual symptoms of PD. The PDQ includes three scales: "psychological and physical symptoms" (6 items), "penile pain" (3 items), and "symptom bother" (4 scored items and 2 yes/no questions). The "psychological and physical symptom" domain has a 5-level Likert scale ranging from "none" to "very severe." Patients must complete items on the "penile pain" domain thinking about the last 24 h, and a numeric scale ranging from 0 to 10 was used to evaluate its severity. The "symptom bother" domain has a 5-level Likert scale ("not at all bothered," "a little bit bothered,").
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 23376705Hellstrom WJ, Feldman R, Rosen RC, Smith T, Kaufman G, Tursi J. Bother and distress associated with Peyronie's disease: validation of the Peyronie's disease questionnaire. J Urol. 2013 Aug;190(2):627-34. doi: 10.1016/j.juro.2013.01.090. Epub 2013 Jan 31.
- Background: PubMed 37464022Garcia-Gomez B, Martinez-Salamanca JI, Sarquella-Geli J, Justo-Quintas J, Garcia-Rojo E, Fernandez-Pascual E, Ruiz-Castane E, Romero-Otero J. Correction: Peyronie's Disease Questionnaire (PDQ): Spanish translation and validation. Int J Impot Res. 2024 Feb;36(1):102. doi: 10.1038/s41443-023-00734-0. No abstract available.
- Background: PubMed 37978202Traunero F, Di Grazia M, Ongaro L, Rizzo M, Cocci A, Verze P, Zucchi A, Cai T, Salame L, Garaffa G, Trombetta C, Liguori G. Validation of the Italian version of the Peyronie's Disease Questionnaire (PDQ). Int J Impot Res. 2024 Sep;36(6):588-591. doi: 10.1038/s41443-023-00792-4. Epub 2023 Nov 17.
- Derived from this study: PubMed 42684278Citamak B, Dogan C, Koroglu MS, Baser A, Ozkaptan O, Cubuk A. Turkish Translation, Validation, and Clinical Utilization of the Peyronie's Disease Questionnaire. Arch Esp Urol. 2026 Aug;79(7):1115-1122. doi: 10.56434/j.arch.esp.urol.aeu007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acibadem University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 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 Turkey (Türkiye). 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?
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?
Reliability and usability of the Turkish translation of the PDQ (time frame: From September 2024 to April 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621420, which also lists 4 linked publications.
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 1 Oct 2024.