Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Pelvic Floor Health Knowledge Assessment: 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: 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: 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: 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: 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: 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: 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: 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.

Study summary

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

Primary outcome measure(s)

• Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score — Baseline
  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.

Trial sites (1)

More Biruni University trials in Turkey