NCT07651566

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 8, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

menopausewomenrespiratory functiongenitourinary function

Outcome Measures

Primary Outcomes (4)

  • Bristol Female Lower Urinary Tract Symptoms Index (BUTSI)

    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.

    at baseline

  • Postmenopausal Sexuality Questionnaire (PSQ)

    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).

    at baseline

  • Respiratory function

    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.

    at baseline.

  • respiratory muscle strength

    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.

    at baseline.

Study Arms (1)

Women in Postmenopausal Period

All women who are postmenopausal and meet the participation criteria.

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All women who are postmenopausal and meet the participation criteria.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Kurne HG, Akbayrak T. The validity and reliability of the Turkish version of the Postmenopause Sexuality Questionnaire. Int J Gynaecol Obstet. 2024 Apr;165(1):188-193. doi: 10.1002/ijgo.15293. Epub 2023 Dec 12.

  • Sarmento ACA, Costa APF, Vieira-Baptista P, Giraldo PC, Eleuterio J Jr, Goncalves AK. Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic. Front Reprod Health. 2021 Nov 15;3:779398. doi: 10.3389/frph.2021.779398. eCollection 2021.

Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Duygu ŞAHİN, PT, PhD.

    Halic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 16, 2026

Study Start

May 1, 2025

Primary Completion

May 1, 2025

Study Completion

March 1, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations