Sjögren and Gynecologic Considerations

NCT ID: NCT05670535

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-11-10

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.

Conditions

Primary Sjögren Syndrome; Vaginitis Candida; Vaginitis; Sexual Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Visual analogue scale (VAS) for dyspareunia

Intervention Type: OTHER

Dyspareunia scores between 0 to 10 points

Visual analogue scale (VAS) for vaginal dryness

Intervention Type: OTHER

Vaginal dryness scores between 0 to 10 points

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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.

Visual analogue scale (VAS) for dyspareunia

Intervention Type: OTHER

Dyspareunia scores between 0 to 10 points

Visual analogue scale (VAS) for vaginal dryness

Intervention Type: OTHER

Vaginal dryness scores between 0 to 10 points

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

Interventions

Visual analogue scale (VAS) for dyspareunia

Dyspareunia scores between 0 to 10 points

Intervention Type: OTHER

Visual analogue scale (VAS) for vaginal dryness

Vaginal dryness scores between 0 to 10 points

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Esin Merve Erol Koç

Medical Doctor, Obstetrician and Gynecologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Mariette X, Criswell LA. Primary Sjogren's Syndrome. N Engl J Med. 2018 Mar 8;378(10):931-939. doi: 10.1056/NEJMcp1702514. No abstract available.

Reference Type: RESULT

PMID: 29514034 (View on PubMed)

Priori R, Minniti A, Derme M, Antonazzo B, Brancatisano F, Ghirini S, Valesini G, Framarino-dei-Malatesta M. Quality of Sexual Life in Women with Primary Sjogren Syndrome. J Rheumatol. 2015 Aug;42(8):1427-31. doi: 10.3899/jrheum.141475. Epub 2015 Jul 1.

Reference Type: RESULT

PMID: 26136488 (View on PubMed)

Mulherin DM, Sheeran TP, Kumararatne DS, Speculand B, Luesley D, Situnayake RD. Sjogren's syndrome in women presenting with chronic dyspareunia. Br J Obstet Gynaecol. 1997 Sep;104(9):1019-23. doi: 10.1111/j.1471-0528.1997.tb12060.x.

Reference Type: RESULT

PMID: 9307528 (View on PubMed)

Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.

Reference Type: RESULT

PMID: 27383445 (View on PubMed)

ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. 2006 May;107(5):1195-1206. doi: 10.1097/00006250-200605000-00049.

Reference Type: RESULT

PMID: 16648432 (View on PubMed)

Other Identifiers

E1-20-1290

Identifier Type: -

Identifier Source: org_study_id