Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome

Completed

• Conditions: Pelvic Organ Prolapse; Urinary Incontinence; Pelvic Floor Disorders; Sexual Dysfunction; Constipation

• Registration Number: NCT04415710
• Lead Sponsor: Akdeniz University

Brief Summary

Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

Detailed Description

Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.

Study Timeline

• Study Start: 2019-02-21
• Primary Completion: 2020-05-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study Completion: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• being between the ages of 18-65
• being a woman,
• having sex partner,
• no smoking, no alcohol

Exclusion Criteria

• physical, psychological, cognitive impairment,
• having a non-Sjögren additional disease,
• malignancy,
• pregnancy,
• no urogenital disease,
• sarcoidosis,
• AIDS,
• anticholinergic drug use,
• had a gynecological or urological operation other than cesarean

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic Floor Distress Inventory PFDI-20	1 week	Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales
Pelvic Floor Impact Questionnaire PFIQ	1 week	Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
Female Sexual Dysfunction Index FSFI	1 week	The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.

Trial Locations

Locations (1)

Ayse Ayan; 🇹🇷 Antalya, Turkey