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Completed

NCT Number: NCT07651566

Relationship Between Genitourinary and Respiratory Symptoms in Postmanopause

The aim of this study is to evaluate the relationship between genitourinary system symptoms and respiratory function and respiratory muscle strength in postmenopausal women.

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Key information

Conditions

Menopause Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

50 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Halic University

Istanbul, Turkey (Türkiye)

About this study

The study included 28 volunteer women who had entered menopause naturally and whose menopausal period had not exceeded eight years. The Bristol Female Lower Urinary Tract Symptoms Index (BFLUTS), the Postmenopausal Sexuality Questionnaire (PSQ), and a spirometer to measure respiratory function were used to evaluate the participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being between 50-64 years of age,
  • having passed menopause no more than eight years ago,
  • having experienced at least one pregnancy,
  • being literate;

Exclusion criteria

  • having received/currently receiving hormone replacement therapy,
  • having any respiratory system disorder;
  • having a serious chronic and/or metabolic disorder that may affect the outcome of the study;
  • having cooperation problems.

Treatment and study plan

Primary outcomes

  1. Bristol Female Lower Urinary Tract Symptoms Index (BUTSI)

    Time frame: at baseline

    The BUTSI, for which a Turkish validity and reliability study has been conducted, consists of five sections evaluating storage symptoms; voiding symptoms ; urinary incontinence ; sexual function ; and quality of life The maximum total score is 60.A higher total score on the scale indicates a more negative impact on sexual life and quality of life, and more severe lower urinary tract symptoms.

  2. Postmenopausal Sexuality Questionnaire (PSQ)

    Time frame: at baseline

    The MSCA, for which Turkish validity and reliability studies have been conducted, consists of a total of 36 items and nine sub-dimensions.The maximum total score is 100. A score of zero indicates the worst sexual function, while a score of 100 indicates the best sexual function (0-100).

  3. Respiratory function

    Time frame: at baseline.

    The evaluation was performed using a Cosmed Pony FX brand spirometer, in accordance with the criteria.A forced vital capacity maneuver test was administered to assess the respiratory function of the participants. During the forced vital capacity maneuver, the participant was asked to take a deep breath and, when they could no longer breathe, to forcefully, quickly, and for an extended period exhale all the air from their lungs, then take another deep breath. As a result of this test, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and peak airflow rate (PEF) values were obtained and recorded.

  4. respiratory muscle strength

    Time frame: at baseline.

    The evaluation was performed using a Cosmed Pony FX brand spirometer. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) tests were performed to assess the strength of the respiratory muscles. For the MIP test, the participant was asked to first completely exhale the air from their lungs, followed by a deep, rapid, and forceful full breath; for the MEP test, the participant was asked to first completely fill their lungs with air, followed by a rapid and forceful full exhale. MIP and MEP values were used as percentages of the expected values for gender and age, and Black and Hyatt equations were used when interpreting the values.

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

Investigation of the Relationship Between Genitourinary System Symptoms, Respiratory Functions, and Respiratory Muscle Strength in the Postmenopausal Period

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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