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

Investigation of the Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis: a Cross-Sectional Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis (SSc); Sexual Dysfunctions; Pelvic Floor Disorder

Detailed Description

Female patients with systemic sclerosis have a high incidence of pelvic floor dysfunction and sexual dysfunction.The association of sexual dysfunction in systemic sclerosis with many disease-related factors has been confirmed. There are numerous studies in the literature investigating the prevalence and risk factors of sexual dysfunction in women with SSc, the number of studies examining the prevalence and effects of pelvic floor dysfunction in SSc is limited. Moreover, no studies were identified in the literature that specifically investigate the relationship between pelvic floor dysfunction and sexual dysfunction.The aim of this study is to evaluate pelvic floor dysfunction and sexual dysfunction in women with SSc, examine the relationship between these dysfunctions, and compare the findings with data from a healthy control group.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Tülay Ülkü Sevim, lecturer; Phone Number: 905349787081; Email: tulayulkusevim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

70 women with systemic sclerosis and 70 healthy women

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
study group; Female patients with systemic sclerosis
Control group; healthy women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Scleroderma Health Assessment Questionnaire will be used.	1 day
disease activity	Modified Rodnan Skin Score will be used.	1 day

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pelvic floor disorders; systemic sclerosis; female sexual dysfunction
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Pregnancy Complications; Skin Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Pelvic Floor Disorders
• Other Study ID Numbers: 142198O

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No