Peyronie Disease Questionnaire (PDQ): Turkish Validation

• Conditions: Peyronie Disease

• Registration Number: NCT06621420
• Lead Sponsor: Acibadem University

Brief 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.

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 Timeline

• Status Verified: 2024-06
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-28
• Last Update Submitted: 2024-09-28
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-10-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• adult patients (≥18 years),
• men,
• diagnosis of PD, except those who have previously received invasive treatment

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability and usability of the Turkish translation of the PDQ	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,").

Trial Locations

Locations (1)

Acibadem University; 🇹🇷 İstanbul, Turkey