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

NCT ID: NCT04816370

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-02
• Study Completion Date: 2021-01-25

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.

Conditions

Primary Sjögren Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

pSS group

primary Sjögren's syndrome group

Group Type: EXPERIMENTAL

FSFI

Intervention Type: DIAGNOSTIC_TEST

2 group and 2 subgroup

Control Group

Control group

Group Type: EXPERIMENTAL

FSFI

Intervention Type: DIAGNOSTIC_TEST

2 group and 2 subgroup

pSS Premenopausal

primary Sjögren's syndrome premenopausal patients

Group Type: EXPERIMENTAL

FSFI

Intervention Type: DIAGNOSTIC_TEST

2 group and 2 subgroup

pSS Postmenopausal

primary Sjögren's syndrome postmenopausal patients

Group Type: EXPERIMENTAL

FSFI

Intervention Type: DIAGNOSTIC_TEST

2 group and 2 subgroup

Interventions

FSFI

2 group and 2 subgroup

Intervention Type: DIAGNOSTIC_TEST

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

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Murat Gozukucuk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murat Gözüküçük

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Research Hospital

Locations

Ankara Training and Education Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 23710558 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31233285 (View on PubMed)

Other Identifiers

A1

Identifier Type: -

Identifier Source: org_study_id