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

NCT04415710 | Completed DMC

• 1 other identifier: 2019-166
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Pelvic Floor Disorders; Pelvic Organ Prolapse; Urinary Incontinence; Constipation

Keywords

pelvic pain; sexual dysfunction; unirary incontinence; constipation; pelvic floor dysfunction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Group

Women with diagnosed Sjogren syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Ayse Ayan

Antalya, Turkey, 07059, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26965411 BACKGROUND

• 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.

  PMID: 25652072 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Pelvic Floor Disorders; Pelvic Organ Prolapse; Urinary Incontinence; Constipation; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Pain; Neurologic Manifestations

Study Officials

• Ayse Ayan

  University of Health Sciences Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: February 21, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 2, 2020
• Last Updated: November 19, 2024

Record last verified: 2020-06

Locations

TU (1)