Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions

Primary Sjögren Syndrome Clinical Trial

Official title:

Primary Sjögren's Syndrome Affects Female Genitalia and Sexual Functions: A Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816370
• Other study ID #: A1
• Status: Completed
• Phase: N/A
• Start date: July 2, 2015
• Est. completion date: January 25, 2021

Study information

• Verified date: March 2021
• Source: Ankara Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 68 women with pSS and 135 healthy female patients were included in the study. All women in the study and control groups were evaluated gynecologically, and genital findings during the examination and variables related to pSS were recorded. Women's sexual functions were evaluated with the Female Sexual Function Index (FSFI) and quality of life was evaluated using the Health Status Questionnaire-Short Form 36.

Description:

This prospective, single-center, cross-sectional case control study will include a total of 68 women with pSS who presented to the rheumatology outpatient clinic of a tertiary care hospital and 135 healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction and had similar age and menopausal status to the pSS group. The diagnosis of pSS was made according to the American-European Consensus Group criteria. Age, gravity, parity, body mass index (BMI), education status, smoking status, menarche age, and menopausal status and duration will be recorded for all participants. Disease duration, serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), anti-nuclear antibody (ANA) positivity, extractable nuclear antigen antibodies panel, extraglandular involvement and salivary gland pathologies were recorded. Disease-related variables (activity and function data, etc.), European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score 28 (DAS28), Health Assessment Questionnaire (HAQ), Visual Analog Scale-Pain (VAS-Pain) and fatigue scores and medicines used for pSS will be evaluated and recorded only in the pSS group. A gynecological examination will be performed in the lithotomy position in all participants in both groups by the same gynecologist with at least 15 years of professional experience. In order to determine vaginal atrophy, shrinkage and thinning of the mucosa, loss of rugae in the vagina and introitus stenosis are taken into consideration. The reduction of subcutaneous fat in the labia majora is evaluated as labial atrophy, and contraction in size and even retraction of the clitoral prepuce is interpreted as clitoral atrophy. Pain sensation on speculum examination will be assessed by VAS (rated from 0 to 10). Vaginal culture and cervico-vaginal smear will be analyzed, and the findings will be recorded.

Women aged over 20 and under 70 years will be included in the study. Pregnant patients and those with known hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders, and communication impairment will be excluded from the study. The Female Sexual Function Index (FSFI), Health Status Questionnaire [Short Form (SF)-36], and Hospital Depression and Anxiety Scale (HADS) will be administered to the women in both groups, and their scores were recorded. The data obtained from the study and control groups will be compared. The patients in the pSS group and healthy controls will be further divided into two subgroups according to their menopause status, and statistical comparisons will also be undertaken between these subgroups. A multivariate linear regression analysis will be performed, and the correlation of sexual function with other parameters is examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 25, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

Clinical Diagnosis of pSS healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction -

Exclusion Criteria:

Pregnancy hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders communication impairment

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Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Diagnostic Test:
• FSFI
2 group and 2 subgroup

Locations

Country	Name	City	State
Turkey	Ankara Training and Education Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Maddali Bongi S, Del Rosso A, Orlandi M, Matucci-Cerinic M. Gynaecological symptoms and sexual disability in women with primary Sjögren's syndrome and sicca syndrome. Clin Exp Rheumatol. 2013 Sep-Oct;31(5):683-90. Epub 2013 May 27. — View Citation

McCoy SS, Sampene E, Baer AN. Association of Sjögren's Syndrome With Reduced Lifetime Sex Hormone Exposure: A Case-Control Study. Arthritis Care Res (Hoboken). 2020 Sep;72(9):1315-1322. doi: 10.1002/acr.24014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Function	The sexual functions of women participating in the study were evaluated in six subdomains, arousal, desire, lubrication, orgasm, pain, and satisfaction.Higher scores demonstrate preferable sexual function. The total score is obtained by adding the scores of six-subdomains	1 day