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

Investigation of the Relationship Between the 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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07059
    • Ayse Ayan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

94 women with Sjögren syndrome with an average age of 48.15 ± 8.73 years were included in the study. 94 women diagnosed as SS according to 2016 ACR-EULAR Classification Criteria for primary Sjögren's syndrome were included in the study by Rheumatology Clinic of Hospital. Ethical approval of the study was obtained from the Interventional Clinical Research Ethics Committee. All women were informed verbally and informed consent forms were signed.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group; Women with diagnosed Sjogren syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Distress Inventory PFDI-20	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	1 week
Pelvic Floor Impact Questionnaire PFIQ	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.	1 week
Female Sexual Dysfunction Index FSFI	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.	1 week

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Study Director: Ayse Ayan, University of Health Sciences Antalya Training and Research Hospital

Publications and helpful links

General Publications

• van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
• Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: sexual dysfunction; constipation; pelvic pain; unirary incontinence; pelvic floor dysfunction
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Eye Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms, Digestive; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Urination Disorders; Mouth Diseases; Pathological Conditions, Anatomical; Pregnancy Complications; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Constipation; Pelvic Floor Disorders; Sjogren's Syndrome
• Other Study ID Numbers: 2019-166

Drug and device information, study documents

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