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

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease With Systemic Sclerosis
• Intervention / Treatment: Other: Pelvic Floor Health Knowledge Assessment; Other: Pelvic Floor Dysfunction Assessment; Other: Core Endurance Assessment; Other: Body Composition Assessment; Other: Sexual Function Assessment; Other: Respiratory Function; Other: Functional Exercise Capacity Assessment; Other: Functional Status Assessment

• Study Type: Observational
• Enrollment (Estimated): 67

Contacts and Locations

• Study Contact: Name: B.Beril Kılıç; Phone Number: 05069496158; Email: fztbkilic@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34103
      • Recruiting
      • Istanbul Faculy of Medicine-Department of Pulmonary Medicine
      • Contact: B.Beril Kılıç; Phone Number: 05069496158; Email: fztbkilic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	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 (%).	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 (%).	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.	Baseline
Maximum Expiratory Pressure	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	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	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	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	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	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	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	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	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).	Baseline
Bioelectrical Impedance Analysis - Body Fat Percentage	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

Collaborators and Investigators

• Sponsor: Biruni University

Publications and helpful links

General Publications

• McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
• Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
• Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
• Zachovajeviene B, Siupsinskas L, Zachovajevas P, Venclovas Z, Milonas D. Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial. Sci Rep. 2019 Dec 16;9(1):19192. doi: 10.1038/s41598-019-55724-4.
• Yakut H, Yalcinkaya G, Ozyurek S, Ozalevli S, Salik Sengul Y, Birlik M. Assessment of diaphragmatic function by ultrasonography in patients with systemic sclerosis and its relation to clinical parameters : A case-control study. Wien Klin Wochenschr. 2023 Oct;135(19-20):528-537. doi: 10.1007/s00508-023-02163-x. Epub 2023 Apr 3.
• Walterspacher S, Schlager D, Walker DJ, Muller-Quernheim J, Windisch W, Kabitz HJ. Respiratory muscle function in interstitial lung disease. Eur Respir J. 2013 Jul;42(1):211-9. doi: 10.1183/09031936.00109512. Epub 2012 Dec 20.
• Umar SB, Griffing L, Garcia H, Foxx-Orenstein AE, DiBaise JK, Crowell MD. The Impact of Pelvic Floor and Lower Gastrointestinal Symptoms on Quality of Life in Women With Systemic Sclerosis. J Clin Gastroenterol. 2016 Jul;50(6):e55-9. doi: 10.1097/MCG.0000000000000405.
• Hermankova B, Spiritovic M, Oreska S, Storkanova H, Mann H, Pavelka K, Senolt L, Vencovsky J, Becvar R, Tomcik M. Effect of an 8-Week Tailored Physiotherapy Program on Sexual Health in Women with Scleroderma and Myositis: A Controlled Pilot Study. Rheumatol Ther. 2023 Aug;10(4):1089-1105. doi: 10.1007/s40744-023-00559-9. Epub 2023 May 23.
• Hermankova B, Spiritovic M, Smucrova H, Oreska S, Storkanova H, Komarc M, Pavelka K, Senolt L, Vencovsky J, Becvar R, Tomcik M. Female Sexual Dysfunction and Pelvic Floor Muscle Function Associated with Systemic Sclerosis: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jan 5;19(1):612. doi: 10.3390/ijerph19010612.
• Dogan H, Altuntas Yilmaz N. Pelvic floor dysfunction symptoms and knowledge level and quality of life in systemic sclerosis women. Women Health. 2025 Sep;65(8):675-683. doi: 10.1080/03630242.2025.2557943. Epub 2025 Sep 9.
• American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
• Alkotob ML, Soltani P, Sheatt MA, Katsetos MC, Rothfield N, Hager WD, Foley RJ, Silverman DI. Reduced exercise capacity and stress-induced pulmonary hypertension in patients with scleroderma. Chest. 2006 Jul;130(1):176-81. doi: 10.1378/chest.130.1.176.
• Al'deges, W. A., & Çelenay, Ş. T. (2021). Development of pelvic floor health knowledge quiz in Turkish people: validity and reliability. Türk Fizyoterapi ve Rehabilitasyon Dergisi, 32(2), 122-131.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: exercise capacity; pulmonary function; pelvic floor dysfunction; core endurance; pelvic floor knowledge
• Additional Relevant MeSH Terms: Circulatory and Respiratory Physiological Phenomena; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Inhalation
• Other Study ID Numbers: 12 (Israel lung Association)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No