Clinical trial NCT04415710: Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome
Official title: Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Pelvic Floor Disorders
Pelvic Organ Prolapse
Urinary Incontinence
Constipation
Keywords: pelvic pain
sexual dysfunction
unirary incontinence
constipation
pelvic floor dysfunction
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 94 women with Sjögren syndrome with an average age of 48.15 ± 8.73 years were included in the study. 94 women diagnosed as SS according to 2016 ACR-EULAR Classification Criteria for primary Sjögren's syndrome were included in the study by Rheumatology Clinic of Hospital. Ethical approval of the study was obtained from the Interventional Clinical Research Ethics Committee. All women were informed verbally and informed consent forms were signed.

Brief summary: Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

Detailed description: Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18-65
* being a woman,
* having sex partner,
* no smoking, no alcohol

Exclusion Criteria:

* physical, psychological, cognitive impairment,
* having a non-Sjögren additional disease,
* malignancy,
* pregnancy,
* no urogenital disease,
* sarcoidosis,
* AIDS,
* anticholinergic drug use,
* had a gynecological or urological operation other than cesarean

Primary outcomes:
measure: Pelvic Floor Distress Inventory PFDI-20
timeFrame: 1 week
measure: Pelvic Floor Impact Questionnaire PFIQ
timeFrame: 1 week
measure: Female Sexual Dysfunction Index FSFI
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Ayse Ayan
Study officials:
affiliation: University of Health Sciences Antalya Training and Research Hospital
name: Ayse Ayan
role: STUDY_DIRECTOR
References:
citation: Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.
citation: van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.