NCT06621420

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

October 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

September 4, 2024

Last Update Submit

September 28, 2024

Conditions

Keywords

PeyronieQuestionnairevalidation

Outcome Measures

Primary Outcomes (1)

  • 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,").

    From September 2024 to April 2025

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPeyronie\'s disease is a male disease associated with penile deformity, so only male patients were included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men living in the Marmara region whose native language is Turkish

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 23376705BACKGROUND
  • Garcia-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.

    PMID: 37464022BACKGROUND
  • Traunero 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.

    PMID: 37978202BACKGROUND

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2024

First Posted

October 1, 2024

Study Start

September 1, 2024

Primary Completion

October 30, 2024

Study Completion

March 30, 2025

Last Updated

October 1, 2024

Record last verified: 2024-06

Locations