Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05670535
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2023-01-02
Brief Title:
Sjögren and Gynecologic Considerations
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Vaginal Infections and Sexual Dysfunction in Women With Primary Sjögrens Syndrome
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sjögrens syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations It is called primary Sjögrens 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 secretionsThe 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
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 secretionsThe 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:
Sjögrens syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations In the absence of another connective tissue disease it is called primary Sjögrens 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 secretionsThe 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 n49 will be compared with women who had not any other disease or complaint rather than vaginal discharge control group n69 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 Sjögrens Syndrome Disease Activity Index ESSDAI and Sjögrens Syndrome Patient Reported Index ESSPRI Sjögrens syndrome disease activity will be also performed Correlation and regression analyses will be also performed for pSS related parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None