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Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

2026년 9월 8일 업데이트: Biruni University

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

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

67

연락처 및 위치

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연구 연락처

연구 장소

  • 터키 (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, 터키 (Türkiye), 34103
        • 모병
        • Istanbul Faculy of Medicine-Department of Pulmonary Medicine
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having a severe chronic comorbid condition,
  • Having any other rheumatologic disease,
  • Having hearing or visual impairments,
  • Having a concomitant neurological, cardiovascular, or orthopedic disorder.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score
기간: 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.
Baseline

2차 결과 측정

결과 측정
측정값 설명
기간
Pulmonary Function Test - Forced Expiratory Volume in One Second
기간: Baseline
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 (%).
Baseline
Pulmonary Function Test - Forced Vital Capacity
기간: Baseline
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 (%).
Baseline
Pulmonary Function Test - Diffusing Capacity of the Lungs for Carbon Monoxide
기간: Baseline
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 (%).
Baseline
Maximum Inspriratory Pressure
기간: Baseline
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.
Baseline
Maximum Expiratory Pressure
기간: Baseline
Maximum Expiratory Pressure (MEP): Expiratory muscle strength will be assessed using a portable electronic respiratory pressure meter (MicroRPM; Micro Medical, UK) in accordance with ATS/ERS guidelines. Participants will perform a maximal expiratory effort with the nose occluded. At least three measurements will be performed, with a minimum 1-minute rest between trials, and the highest valid value will be recorded. MEP will be reported in cmH₂O, with higher values indicating greater expiratory muscle strength.
Baseline
Functional Exercise Capacity - 6-Minute Walk Test
기간: Baseline
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) in accordance with ATS guidelines. Participants will be instructed to walk as far as possible at their own pace along a 30-meter flat corridor for six minutes. A 10-minute seated rest period will be provided before the test. Resting during the test will be permitted without stopping the timer. The total distance walked in six minutes will be recorded in meters (m), with a greater distance indicating better functional exercise capacity.
Baseline
Trunk Flexor Endurance - McGill Core Endurance Test
기간: Baseline
Trunk flexor endurance will be assessed using the McGill Core Endurance Test. Participants will maintain a standardized position with the knees flexed to 90° and the trunk at 60°, with the arms crossed over the chest. The duration for which the position can be maintained will be recorded in seconds (s), with a longer duration indicating greater trunk flexor endurance.
Baseline
Trunk Extensor Endurance - McGill Core Endurance Test
기간: Baseline
Trunk extensor endurance will be assessed using the McGill Core Endurance Test. Participants will maintain the trunk horizontally unsupported in the prone position while the lower body is stabilized. The test will end when the participant is unable to maintain the required position. The duration will be recorded in seconds (s), with a longer duration indicating greater trunk extensor endurance.
Baseline
Lateral Trunk Endurance - McGill Core Endurance Test
기간: Baseline
Lateral trunk endurance will be assessed using a modified side-bridge test with the knees flexed. Participants will support the body on the lower elbow and knees and maintain the required position for as long as possible. The test will end when the participant is unable to maintain the position. The duration will be recorded in seconds (s), with a longer duration indicating greater lateral trunk endurance.
Baseline
Cough-Related Quality of Life - Leicester Cough Questionnaire
기간: Baseline
Leicester Cough Questionnaire (LCQ): The impact of cough on health-related quality of life will be assessed using the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire comprising physical, psychological, and social domains. The total score ranges from 3 to 21, with higher scores indicating better cough-related quality of life and a better outcome. The Turkish version of the LCQ has been demonstrated to be valid and reliable.
Baseline
Modified Medical Research Council Dyspnea Scale
기간: Baseline
Modified Medical Research Council (mMRC) Dyspnea Scale: Dyspnea during activities of daily living will be assessed using the modified Medical Research Council (mMRC) Dyspnea Scale. The scale ranges from 0 to 4, with higher scores indicating greater dyspnea severity and a worse outcome.
Baseline
Sexual Function - Arizona Sexual Experiences Scale
기간: Baseline
Sexual function will be assessed using the Arizona Sexual Experiences Scale (ASEX), a 5-item scale evaluating sexual drive, arousal, physiological arousal, ability to reach orgasm, and satisfaction from orgasm. The total score ranges from 5 to 30, with higher scores indicating greater sexual dysfunction and a worse outcome. A total score of ≥19, a score of 5 or 6 on any single item, or a score of ≥4 on three or more items indicates sexual dysfunction. The Turkish version of the ASEX has been demonstrated to be valid and reliable.
Baseline
Disease-Related Functional Status - Scleroderma Health Assessment Questionnaire
기간: Baseline
Functional status and limitations in activities of daily living will be assessed using the Scleroderma Health Assessment Questionnaire (SHAQ). The questionnaire evaluates disability and disease-related limitations associated with systemic sclerosis, including Raynaud's phenomenon, digital ulcers, pulmonary symptoms, gastrointestinal symptoms, and overall disease severity. Higher scores indicate greater disability and a worse functional outcome.
Baseline
Pelvic Floor Health Knowledge - Pelvic Floor Health Knowledge Test
기간: Baseline
Pelvic floor health knowledge will be assessed using the Pelvic Floor Health Knowledge Quiz (PFHKQ), a 29-item questionnaire evaluating knowledge of pelvic floor function and dysfunction, risk and etiology, and diagnosis and treatment. Each correct response is scored as 1 and incorrect or "I don't know" responses as 0, resulting in a total score ranging from 0 to 29. Higher scores indicate greater pelvic floor health knowledge and a better outcome.
Baseline

기타 결과 측정

결과 측정
측정값 설명
기간
Bioelectrical Impedance Analysis - Muscle Mass
기간: Baseline
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).
Baseline
Bioelectrical Impedance Analysis - Body Mass Index
기간: Baseline
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.
Baseline
Bioelectrical Impedance Analysis - Body Weight
기간: Baseline
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).
Baseline
Bioelectrical Impedance Analysis - Body Fat Mass
기간: Baseline
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).
Baseline
Bioelectrical Impedance Analysis - Body Fat Percentage
기간: Baseline
Body fat percentage will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions. Body fat percentage will be recorded as a percentage (%).
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Biruni University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 1일

기본 완료 (추정된)

2026년 9월 20일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 8월 26일

QC 기준을 충족하는 최초 제출

2026년 9월 8일

처음 게시됨 (실제)

2026년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 8일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 12 (Israel lung Association)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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