Sjögren and Gynecologic Considerations

Completed

• Conditions: Vaginitis Candida; Vaginitis; Sexual Dysfunction; Primary Sjögren Syndrome
• Interventions: Other: Visual analogue scale (VAS) for dyspareunia; Other: Visual analogue scale (VAS) for vaginal dryness; Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI); Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

• Registration Number: NCT05670535
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. It is called primary Sjögren's syndrome (pSS) in absence of another connective tissue disease. The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be involved which precede such as xerotrachea in upper airway, atrophic gastritis and pancreatitis in gastrointestinal tract, and dryness in vaginal mucosa.

Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters.

Detailed Description

Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. In the absence of another connective tissue disease, it is called primary Sjögren's syndrome (pSS). The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be affected including the vaginal mucosa. Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters. In this prospective cohort study, we planned to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). Besides the physical examination and gynecological evaluation including sterile speculum examination enabling swab sampling for vaginal discharge and PAP smear; the Visual analogue scales (VAS) for dyspareunia, and vaginal dryness and The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), and Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's syndrome disease activity will be also performed. Correlation and regression analyses will be also performed for pSS related parameters.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-11-10
• Status Verified: 2023-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

• All participants are recruited from women who consecutively applied to outpatient clinic.
• Normally menstruating women at reproductive age (without menopause) for all participants.
• Regular sexual activity with single sexual partner for all participants.
• Receiving only hydroxychloroquine sulfate treatment for women with pSS.
• Presence of the symptoms of vaginitis for all participants.
• Without any known disease including autoimmune disorders for women in control group.

Exclusion Criteria

• Women with the pelvic anatomical structural abnormalities
• History of any type of cancer including gynecological cancers, chemotherapy, and/or radiotherapy,
• Endometriosis, chronic cervicitis, menopause, pregnancy, lactation, use of hormonal contraceptive medication, use of vaginal estrogen, pre-malign or malign cytology at Papanicolaou (PAP) smear, having intrauterine device,
• Smoking,
• Chronic diseases (diabetes mellitus, psychiatric disorders,
• Multiple sexual partners, sexually transmitted infections including gonorrhea, chlamydia, genital herpes, and/or mycoplasma, mixed vaginal infections,
• Urinary tract infection in last three months,
• Antibiotic medication at last one month,
• Administration of drugs which may lead vaginal dryness including antihistaminics, antidepressants, and anti-hypertensives,
• Treatment with glucocorticoids, biologic disease modifying anti-rheumatic drugs, or immune-suppressive agents at last three months
• Women who had sexual partners with any sexual dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women without pSS (Control group)	The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)	* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.
pSS group (Study group)	The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)	* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.
pSS group (Study group)	The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)	* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.
Women without pSS (Control group)	Visual analogue scale (VAS) for vaginal dryness	* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.
pSS group (Study group)	Visual analogue scale (VAS) for dyspareunia	* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.
pSS group (Study group)	Visual analogue scale (VAS) for vaginal dryness	* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.
Women without pSS (Control group)	Visual analogue scale (VAS) for dyspareunia	* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.
Women without pSS (Control group)	The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)	* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.

Primary Outcome Measures

Name	Time	Method
Vaginal candidiasis	20 minutes	Culture of swab sampling from vaginal fluid at Sabouraud dextrose agar plates incubated in CO2 for evaluation of candida
Acute vaginitis	10 minutes	Laboratory assessment of vaginal swab sampling from vaginal fluid for bacterial vaginosis
Visual analogue scale for vaginal dryness	20 minutes	The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Visual analogue scale for dyspareunia	20 minutes	The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)	20 minutes	he severity of patient reported symptoms regarding Sjögren's Syndrome, scored between 0 (no symptoms) to 10 (worst symptoms) points.
The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)	20 minutes	The severity of clinical signs regarding Sjögren's Syndrome disease activity, scored between 0 (no symptoms) to 3 (worst symptoms) points.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey