Clinical trial NCT04816370: Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions
Official title: Primary Sjögren's Syndrome Affects Female Genitalia and Sexual Functions: A Case Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Sjögren Syndrome
Keywords: primary Sjögren's Syndrome
vaginal atrophy
sexual dysfunction
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-25
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

-

Primary outcomes:
measure: Sexual Function
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Education Hospital
Study officials:
affiliation: Ankara Training and Research Hospital
name: Murat Gözüküçük
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maddali Bongi S, Del Rosso A, Orlandi M, Matucci-Cerinic M. Gynaecological symptoms and sexual disability in women with primary Sjogren's syndrome and sicca syndrome. Clin Exp Rheumatol. 2013 Sep-Oct;31(5):683-90. Epub 2013 May 27.
citation: McCoy SS, Sampene E, Baer AN. Association of Sjogren'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.