Sjögren and Gynecologic Considerations

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.

Conditions

• Primary Sjögren Syndrome
• Vaginitis Candida
• Vaginitis
• Sexual Dysfunction

Interventions

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent

  lead OTHER

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-10-15

Completion

2022-11-10

Countries

• Turkey (Türkiye)

Study Locations