Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome

NCT ID: NCT04415710

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-21

Study Completion Date

2020-06-02

Brief Summary

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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

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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.

Conditions

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Sexual Dysfunction Pelvic Floor Disorders Pelvic Organ Prolapse Urinary Incontinence Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group

Women with diagnosed Sjogren syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Alime Buyuk

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Ayan

Role: STUDY_DIRECTOR

University of Health Sciences Antalya Training and Research Hospital

Locations

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Ayse Ayan

Antalya, Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26965411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25652072 (View on PubMed)

Other Identifiers

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2019-166

Identifier Type: -

Identifier Source: org_study_id

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