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Interstitial Lung Disease With Systemic SclerosisNCT07817160

Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

An observational study of Interstitial Lung Disease With Systemic Sclerosis, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Systemic sclerosis (SSc) is a heterogeneous multisystem disease characterized by vascular dysfunction, immune abnormalities, and progressive fibrosis of the skin and internal organs. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Pelvic Floor Health Knowledge Assessment, Pelvic Floor Dysfunction Assessment and Core Endurance Assessment
How many people
37 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to 6 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Faculy of Medicine-Department of Pulmonary Medicine

    Istanbul, Istanbul, 34103

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Pelvic Floor Health Knowledge Assessment, Pelvic Floor Dysfunction Assessment, Core Endurance Assessment, Body Composition Assessment, Sexual Function Assessment
Keywords
core endurance, pelvic floor dysfunction, exercise capacity, pelvic floor knowledge, pulmonary function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic Floor Health Knowledge AssessmentOther

    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 AssessmentOther

    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 AssessmentOther

    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 AssessmentOther

    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 AssessmentOther

    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 FunctionOther

    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 AssessmentOther

    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 AssessmentOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

Secondary outcomes (14)

  1. 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 (%).

    Measured: Baseline

  2. 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 (%).

    Measured: Baseline

  3. 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 (%).

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: Baseline

  9. 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.

    Measured: Baseline

  10. 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.

    Measured: Baseline

  11. 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.

    Measured: Baseline

  12. 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.

    Measured: Baseline

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Aug 2026
  3. Primary completion6 Oct 2026
  4. Study completion6 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07817160
Sponsor's protocol ID
12
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31844133

  • 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.

    PubMed 37010595

  • 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.

    PubMed 23258788

  • 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.

    PubMed 26325189

  • 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.

    PubMed 10453772

  • 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.

    PubMed 37221419

  • 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.

    PubMed 35010872

  • 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.

    PubMed 40925919

  • 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.

    PubMed 12668799

  • 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.

    PubMed 11744914

  • 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.

    PubMed 11790668

  • 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.

    PubMed 16840399

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Disease With Systemic Sclerosis, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07817160, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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