search
Back to results

Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions

Primary Purpose

Primary Sjögren Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
FSFI
Sponsored by
Ankara Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Primary Sjögren Syndrome focused on measuring primary Sjögren's Syndrome, vaginal atrophy, sexual dysfunction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Clinical Diagnosis of pSS healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction -

Exclusion Criteria:

Pregnancy hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders communication impairment

-

Sites / Locations

  • Ankara Training and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

pSS group

Control Group

pSS Premenopausal

pSS Postmenopausal

Arm Description

primary Sjögren's syndrome group

Control group

primary Sjögren's syndrome premenopausal patients

primary Sjögren's syndrome postmenopausal patients

Outcomes

Primary Outcome Measures

Sexual Function
The sexual functions of women participating in the study were evaluated in six subdomains, arousal, desire, lubrication, orgasm, pain, and satisfaction.Higher scores demonstrate preferable sexual function. The total score is obtained by adding the scores of six-subdomains

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
March 24, 2021
Sponsor
Ankara Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04816370
Brief Title
Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions
Official Title
Primary Sjögren's Syndrome Affects Female Genitalia and Sexual Functions: A Case Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2, 2015 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A total of 68 women with pSS and 135 healthy female patients were included in the study. All women in the study and control groups were evaluated gynecologically, and genital findings during the examination and variables related to pSS were recorded. Women's sexual functions were evaluated with the Female Sexual Function Index (FSFI) and quality of life was evaluated using the Health Status Questionnaire-Short Form 36.
Detailed Description
This prospective, single-center, cross-sectional case control study will include a total of 68 women with pSS who presented to the rheumatology outpatient clinic of a tertiary care hospital and 135 healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction and had similar age and menopausal status to the pSS group. The diagnosis of pSS was made according to the American-European Consensus Group criteria. Age, gravity, parity, body mass index (BMI), education status, smoking status, menarche age, and menopausal status and duration will be recorded for all participants. Disease duration, serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), anti-nuclear antibody (ANA) positivity, extractable nuclear antigen antibodies panel, extraglandular involvement and salivary gland pathologies were recorded. Disease-related variables (activity and function data, etc.), European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score 28 (DAS28), Health Assessment Questionnaire (HAQ), Visual Analog Scale-Pain (VAS-Pain) and fatigue scores and medicines used for pSS will be evaluated and recorded only in the pSS group. A gynecological examination will be performed in the lithotomy position in all participants in both groups by the same gynecologist with at least 15 years of professional experience. In order to determine vaginal atrophy, shrinkage and thinning of the mucosa, loss of rugae in the vagina and introitus stenosis are taken into consideration. The reduction of subcutaneous fat in the labia majora is evaluated as labial atrophy, and contraction in size and even retraction of the clitoral prepuce is interpreted as clitoral atrophy. Pain sensation on speculum examination will be assessed by VAS (rated from 0 to 10). Vaginal culture and cervico-vaginal smear will be analyzed, and the findings will be recorded. Women aged over 20 and under 70 years will be included in the study. Pregnant patients and those with known hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders, and communication impairment will be excluded from the study. The Female Sexual Function Index (FSFI), Health Status Questionnaire [Short Form (SF)-36], and Hospital Depression and Anxiety Scale (HADS) will be administered to the women in both groups, and their scores were recorded. The data obtained from the study and control groups will be compared. The patients in the pSS group and healthy controls will be further divided into two subgroups according to their menopause status, and statistical comparisons will also be undertaken between these subgroups. A multivariate linear regression analysis will be performed, and the correlation of sexual function with other parameters is examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjögren Syndrome
Keywords
primary Sjögren's Syndrome, vaginal atrophy, sexual dysfunction

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pSS group
Arm Type
Experimental
Arm Description
primary Sjögren's syndrome group
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Control group
Arm Title
pSS Premenopausal
Arm Type
Experimental
Arm Description
primary Sjögren's syndrome premenopausal patients
Arm Title
pSS Postmenopausal
Arm Type
Experimental
Arm Description
primary Sjögren's syndrome postmenopausal patients
Intervention Type
Diagnostic Test
Intervention Name(s)
FSFI
Intervention Description
2 group and 2 subgroup
Primary Outcome Measure Information:
Title
Sexual Function
Description
The sexual functions of women participating in the study were evaluated in six subdomains, arousal, desire, lubrication, orgasm, pain, and satisfaction.Higher scores demonstrate preferable sexual function. The total score is obtained by adding the scores of six-subdomains
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of pSS healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction - Exclusion Criteria: Pregnancy hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders communication impairment -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Gözüküçük
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Education Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23710558
Citation
Maddali Bongi S, Del Rosso A, Orlandi M, Matucci-Cerinic M. Gynaecological symptoms and sexual disability in women with primary Sjogren's syndrome and sicca syndrome. Clin Exp Rheumatol. 2013 Sep-Oct;31(5):683-90. Epub 2013 May 27.
Results Reference
result
PubMed Identifier
31233285
Citation
McCoy SS, Sampene E, Baer AN. Association of Sjogren's Syndrome With Reduced Lifetime Sex Hormone Exposure: A Case-Control Study. Arthritis Care Res (Hoboken). 2020 Sep;72(9):1315-1322. doi: 10.1002/acr.24014.
Results Reference
result

Learn more about this trial

Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions

We'll reach out to this number within 24 hrs