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NCT07817160Completed

Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

Association of Pelvic Floor Dysfunction With Pulmonary Function, Respiratory Muscle Strength, and Exercise Capacity in Patients With Systemic Sclerosis With Pulmonary Involvement: A Cross-Sectional Study

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
37 (actual)
First submitted
26 Aug 2026
Start date
1 Aug 2026
Primary completion date
6 Oct 2026
Lead sponsor
Biruni University
NCT number
NCT07817160

What you commit to

  • Study type: Observational
  • Participants enrolled: 37
  • From 1 Aug 2026 to the primary completion date, 6 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having a concomitant neurological, cardiovascular, or orthopedic disorder.

Other illness

  • Having a severe chronic comorbid condition,
  • Having any other rheumatologic disease,

Other

  • Having hearing or visual impairments,

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istanbul Faculy of Medicine-Department of Pulmonary Medicine
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.