Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

ConditionInterstitial Lung Disease With Systemic Sclerosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-70

SponsorBiruni University

About this trial

Systemic sclerosis (SSc) is a heterogeneous multisystem disease characterized by vascular dysfunction, immune abnormalities, and progressive fibrosis of the skin and internal organs. Pulmonary involvement, particularly interstitial lung disease (ILD), is one of the most common and clinically important manifestations of SSc and may lead to impaired pulmonary function, respiratory muscle weakness, reduced diaphragmatic function, and decreased exercise capacity. In addition to pulmonary involvement, systemic inflammation, physical inactivity, nutritional disturbances, and musculoskeletal manifestations may contribute to generalized skeletal muscle dysfunction in individuals with SSc.

Pelvic floor dysfunction, including urinary and fecal incontinence, pelvic organ prolapse, pelvic pain, and sexual dysfunction, has also been reported in individuals with SSc. Previous studies have suggested that vascular dysfunction, tissue fibrosis, and structural and functional abnormalities of the pelvic floor may contribute to these symptoms. Furthermore, impaired pelvic floor and sexual function in women with SSc have been associated with several disease-related characteristics, including dyspnea, interstitial lung disease, reduced physical activity, functional disability, and impaired quality of life.

The pelvic floor muscles form the inferior component of the core muscle system and function synergistically with the diaphragm and abdominal muscles to regulate intra-abdominal pressure. Coordinated activity between the diaphragm and pelvic floor muscles during respiration has been demonstrated. Therefore, pulmonary and respiratory muscle involvement in SSc may potentially be associated with impaired pelvic floor function. However, the relationships between pelvic floor dysfunction and pulmonary function, respiratory muscle strength, exercise capacity, and core endurance in patients with SSc with pulmonary involvement remain insufficiently understood. Investigating these relationships may contribute to a more comprehensive understanding of pelvic floor dysfunction and its associated factors in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meeting the 2013 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for systemic sclerosis (SSc),

Having pulmonary involvement,

Being a woman aged 18-70 years

Disqualifiers

Having a severe chronic comorbid condition,

Having any other rheumatologic disease,

Having hearing or visual impairments,

Having a concomitant neurological, cardiovascular, or orthopedic disorder.

Trial population

Women aged 18-70 years diagnosed with systemic sclerosis according to the 2013 EULAR/ACR classification criteria and with pulmonary involvement will be recruited from patients referred from the Department of Pulmonary Medicine, Istanbul Faculty of Medicine. Participants will undergo assessment of pelvic floor dysfunction and related pulmonary and functional parameters.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Pelvic Floor Health Knowledge Assessment
Other intervention
Pelvic floor health knowledge will be assessed using the Pelvic Floor Health Knowledge Test. The questionnaire consists of 29 items covering pelvic floor function and dysfunction, risk factors and etiology, and diagnosis and treatment. Higher scores indicate greater knowledge of pelvic floor health.
Pelvic Floor Dysfunction Assessment
Other intervention
Pelvic floor dysfunction will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20), a 20-item questionnaire evaluating symptoms and symptom-related distress associated with pelvic floor disorders. It consists of three subscales and provides a total score ranging from 0 to 300, with higher scores indicating greater symptom burden.
Core Endurance Assessment
Other intervention
Core endurance will be assessed using the McGill core endurance tests, including trunk flexor, trunk extensor, and lateral trunk endurance tests. Participants will maintain standardized test positions for as long as possible, and endurance time will be recorded in seconds.
Body Composition Assessment
Other intervention
Body composition will be assessed using bioelectrical impedance analysis with a Tanita BC-730 InnerScan body composition analyzer. Body fat mass and muscle mass will be recorded in kilograms under standardized measurement conditions.
Sexual Function Assessment
Other intervention
Sexual function will be assessed using the Arizona Sexual Experiences Scale (ASEX), a five-item questionnaire evaluating sexual drive, arousal, physiological arousal, ability to reach orgasm, and satisfaction from orgasm. Higher scores indicate greater sexual dysfunction.
Respiratory Function
Other intervention
Respiratory function will be assessed using pulmonary function testing and DLCO according to ATS criteria. Respiratory muscle strength will be evaluated by maximal inspiratory (MIP) and expiratory (MEP) pressures using a MicroRPM device according to ATS/ERS recommendations. Cough-related quality of life will be assessed using the Leicester Cough Questionnaire (LCQ), and dyspnea using the modified Medical Research Council (mMRC) Dyspnea Scale.
Functional Exercise Capacity Assessment
Other intervention
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible for six minutes along a 30-meter corridor. The total distance walked will be recorded in meters.
Functional Status Assessment
Other intervention
Disease-related functional status will be assessed using the Scleroderma Health Assessment Questionnaire (SHAQ). The questionnaire evaluates functional limitations and disease-specific manifestations associated with systemic sclerosis, with higher scores indicating greater functional impairment.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score

A 20-item questionnaire assessing pelvic floor symptoms across three subscales: POPDI-6, UDI-6, and CRADI-8 will be used. The total score ranges from 0 to 300, with higher scores indicating greater symptom-related distress and worse pelvic floor health. The Turkish validity and reliability were established.

Time frame

Baseline

Secondary outcomes

Pulmonary Function Test - Forced Expiratory Volume in One Second

Pulmonary function will be assessed using a spirometry system (ZAN 300 MGA) in accordance with American Thoracic Society (ATS) acceptability criteria. Forced expiratory volume in one second (FEV₁) will be recorded and reported as percent predicted (%).

Time frame

Baseline

Pulmonary Function Test - Forced Vital Capacity

Pulmonary function will be assessed using a spirometry system (ZAN 300 MGA) in accordance with American Thoracic Society (ATS) acceptability criteria. Forced vital capacity (FVC) will be recorded as a measure of pulmonary function and reported as percent predicted (%).

Time frame

Baseline

Pulmonary Function Test - Diffusing Capacity of the Lungs for Carbon Monoxide

Diffusing capacity of the lungs for carbon monoxide (DLCO) will be assessed using the ZAN 300 MGA system in accordance with standardized testing procedures and reported as percent predicted (%).

Time frame

Baseline

Maximum Inspriratory Pressure

Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed using a portable electronic respiratory pressure meter (MicroRPM; Micro Medical, UK) in accordance with ATS/ERS guidelines. MIP will be measured during a maximal inspiratory effort (Müller maneuver) with the nose occluded. At least three measurements will be performed with a minimum 1-minute rest between trials. MIP will be reported in cmH₂O, with higher absolute values indicating greater inspiratory muscle strength.

Time frame

Baseline

Other outcomes

Bioelectrical Impedance Analysis - Muscle Mass

Muscle mass will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions. Muscle mass will be recorded in kilograms (kg).

Time frame

Baseline

Bioelectrical Impedance Analysis - Body Mass Index

Body Mass Index (BMI): Body mass index (BMI) will be calculated using measured body weight and height as weight in kilograms divided by height in meters squared (kg/m²). BMI will be reported in kg/m².

Time frame

Baseline

Bioelectrical Impedance Analysis - Body Weight

Body weight will be measured using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions. Participants will be assessed barefoot and wearing light clothing. Body weight will be recorded in kilograms (kg).

Time frame

Baseline

Bioelectrical Impedance Analysis - Body Fat Mass

Body fat mass will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions. Body fat mass will be recorded in kilograms (kg).

Time frame

Baseline

Sponsors and contacts

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Biruni University

Lead sponsor

Source ClinicalTrials.gov

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