Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

NCT06769399 | Not Yet Recruiting

• 1 other identifier: 142198O
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Conditions

Systemic Sclerosis (SSc); Sexual Dysfunctions; Pelvic Floor Disorder

Keywords

systemic sclerosis; female sexual dysfunction; pelvic floor disorders

Outcome Measures

Primary Outcomes (3)

• pelvic floor dysfunction

  Pelvic Floor Distress Inventory-20 (PFDI-20) will be used.The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory-8 (CRADI-8).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.

  1 day

• sexual dysfunction

  Female Sexual Function Index (FSFI) will be used.The FSFI is a 19-item patient-reported outcome measure, consisting of 6 separate domains of female sexual function, namely desire (items 1-2), arousal (3-6), lubrication (7-10), orgasm (11-13), satisfaction (14-16), and pain (17-19).Total scores range from 2-30 with lower scores corresponding to worse sexual functioning.

  1 day

• Pelvic Floor Dysfunction

  Pelvic Floor Impact Questionnaire-7(PFIQ-7). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out. It includes scales from the Urinary Impact Questionnaire (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7), and the Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7), which are short-forms of their the longer versions.The PFIQ-7 consists of 7 questions that need to be answered 3 times each considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

  1 day

Secondary Outcomes (2)

• Functional Capacity

  1 day

• disease activity

  1 day

Study Arms (2)

study group

Female patients with systemic sclerosis

Control group

healthy women

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

70 women with systemic sclerosis and 70 healthy women

You may qualify if:

• female gender
• being between 18-64 years old
• having a diagnosis of systemic sclerosis (SSc)
• being sexually active, and not having entered menopause
• The control group will consist of healthy women aged 18-64 years who are sexually active, have not entered menopause, have no history of urological or gynecological surgeries other than cesarean section, and have no rheumatologic or severe chronic diseases.

You may not qualify if:

• the presence of current or past rheumatologic diseases other than SSc
• the presence of current urogynecological diseases
• a history of urological or gynecological surgeries other than cesarean section.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Scleroderma, Systemic; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Tülay Ülkü Sevim, lecturer

CONTACT

905349787081; tulayulkusevim@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 15, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share