Clinical Trial on Peyronie Disease - Clinical Trials Registry

Study Overview

Status

Enrolling by invitation

Conditions

Peyronie Disease

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - İstanbul, Turkey
    - Acibadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men living in the Marmara region whose native language is Turkish

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,").	From September 2024 to April 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)