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

Urinary Incontinence Clinical Trial

Official title:

Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415710
• Other study ID #: 2019-166
• Status: Completed
• Start date: February 21, 2019
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2, 2020
• Est. primary completion date: May 30, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse
• Sexual Dysfunction
• Sjogren's Syndrome
• Urinary Incontinence

Locations

Country	Name	City	State
Turkey	Ayse Ayan	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjögren'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. — View Citation

van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjögren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Floor Distress Inventory PFDI-20	Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales	1 week
Primary	Pelvic Floor Impact Questionnaire PFIQ	Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.	1 week
Primary	Female Sexual Dysfunction Index FSFI	The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.	1 week