Sjögren and Gynecologic Considerations

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Completed

CT.gov ID

NCT05670535

Collaborator

(none)

118

Enrollment

Location

20.3

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjögren Syndrome Vaginitis Candida Vaginitis Sexual Dysfunction	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)

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 Design

Study Type:

Observational

Actual Enrollment :

118 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vaginal Infections and Sexual Dysfunction in Women With Primary Sjögren's Syndrome

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Oct 15, 2022

Actual Study Completion Date :

Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
pSS group (Study group) 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.	Other: Visual analogue scale (VAS) for dyspareunia Dyspareunia scores between 0 to 10 points Other: Visual analogue scale (VAS) for vaginal dryness Vaginal dryness scores between 0 to 10 points Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points
Women without pSS (Control group) Women without any known disease. At reproductive age (without menopause). Presence of the symptoms of vaginitis.	Other: Visual analogue scale (VAS) for dyspareunia Dyspareunia scores between 0 to 10 points Other: Visual analogue scale (VAS) for vaginal dryness Vaginal dryness scores between 0 to 10 points Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points

Arm

Intervention/Treatment

pSS group (Study group)

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.

Other: Visual analogue scale (VAS) for dyspareunia

Dyspareunia scores between 0 to 10 points

Other: Visual analogue scale (VAS) for vaginal dryness

Vaginal dryness scores between 0 to 10 points

Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)

Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points

Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points

Women without pSS (Control group)

Women without any known disease. At reproductive age (without menopause). Presence of the symptoms of vaginitis.

Other: Visual analogue scale (VAS) for dyspareunia

Dyspareunia scores between 0 to 10 points

Other: Visual analogue scale (VAS) for vaginal dryness

Vaginal dryness scores between 0 to 10 points

Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)

Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points

Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points

Outcome Measures

Primary Outcome Measures

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 dyspareunia [20 minutes]
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Visual analogue scale for vaginal dryness [20 minutes]
The severity of symptoms 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

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