Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions
Condition: Primary Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): FSFI
Intervention type(s): Diagnostic Test
Intervention description(s): 2 group and 2 subgroup
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: primary Sjögren's Syndrome; vaginal atrophy; sexual dysfunction