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

January 9, 2025 updated by: Tulay Ulku SEVIM, Istanbul University - Cerrahpasa

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
study group
Female patients with systemic sclerosis
Control group
healthy women

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pelvic floor dysfunction
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 1 day
Scleroderma Health Assessment Questionnaire will be used.
1 day
disease activity
Time Frame: 1 day
Modified Rodnan Skin Score will be used.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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