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Completed

NCT Number: NCT04415710

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

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.

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Key information

Conditions

Sexual Dysfunction Constipation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Organ Prolapse Pelvic Pain Pregnancy Complications Prolapse Sexual Dysfunction, Physiological Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ayse Ayan

Antalya, Turkey, 07059, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pelvic Floor Distress Inventory PFDI-20

    Time frame: 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

  2. Pelvic Floor Impact Questionnaire PFIQ

    Time frame: 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.

  3. Female Sexual Dysfunction Index FSFI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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