"Validity and Reliability of Pelvic Floor Distress Inventory-20 in Primary Sjögren's Syndrome"

"Investigation of the Validity and Reliability of the Pelvic Floor Distress Inventory-20 in Individuals With Primary Sjögren's Syndrome."

The aim of this study is to examine the Turkish validity and reliability of the Pelvic Floor Distress Inventory-20 in patients with pSS.

Study Overview

• Status: Completed
• Conditions: Sjogren Syndrome
• Intervention / Treatment: Other: the validity and reliability study

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Denizli
    • Pamukkale, Denizli, Turkey (Türkiye), 20000
      • Pamukkale Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Sjogren syndrome group

Description

Inclusion Criteria:

• Being diagnosed with Primary Sjögren's Syndrome by the PAÜ Rheumatology clinic
• Being between the ages of 18 and 65
• Volunteering to participate in the study

Exclusion Criteria:

• Presence of neurological disease
• Presence of any orthopedic problem that may affect functionality
• History of orthopedic surgery
• Presence of psychiatric disorder that may affect cooperation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sjogren syndrome; The Sjogren syndrome group will consist of patients over the age of 18 who apply to the Rheumatology Department of Pamukkale University and meet the inclusion criteria.	Other: the validity and reliability study; "To obtain the validity and reliability of the questionnaire in individuals with Sjögren's syndrome."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Distress Inventory-20 (PTDE-20)	There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	The patient is asked to rate their complaints of fatigue, pain, and dryness on a scale from 1 to 10, and the arithmetic average of the scores obtained from these three questions is calculated. An ESSPRI score below 5 is considered an acceptable disease status, while a score of 5 or above is considered an indicator of high disease activity.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Visual Analog Scale (VAS)	VAS is used to convert certain values that cannot be measured numerically into numerical form. The patient is asked to indicate where their condition fits on this line by drawing a line, placing a dot, or marking a point. It is evaluated on a scale from 0 to 10.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health assessment questionnaire (HAQ)	This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Cognitive Exercise Therapy Approach (BETY)	This scale has 30 items. The scale is scored with a 5-point Likert system.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sjogren syndrome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: Pamukkale U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No