MenopauseNCT07651566
Relationship Between Genitourinary and Respiratory Symptoms in Postmanopause
An observational study of Menopause, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Mar 2026
- How long will I take part?
- 1 Day
- 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 50 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women who are postmenopausal and meet the participation criteria.
Who may be able to join
- being between 50-64 years of age,
- having passed menopause no more than eight years ago,
- having experienced at least one pregnancy,
- being literate;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Genitourinary System Symptoms, Respiratory Functions, and Respiratory Muscle Strength in the Postmenopausal Period
The aim of this study is to evaluate the relationship between genitourinary system symptoms and respiratory function and respiratory muscle strength in postmenopausal women.
Read the detailed description
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.
- Conditions
- Menopause
- Keywords
- menopause, women, respiratory function, genitourinary function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women in Postmenopausal Period | All women who are postmenopausal and meet the participation criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 May 2025
- Primary completion1 May 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu ŞAHİN, PT, PhD., Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651566
- Sponsor's protocol ID
- 02.06.26
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38084782Sarmento 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.
PubMed 36304000
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Genitourinary System Symptoms, Respiratory Functions, and Respiratory Muscle Strength in the Postmenopausal Period
- ClinicalTrials.gov ID
- NCT07651566
- Acronym / sponsor ID
- 02.06.26
- Conditions
- Menopause
- Keywords
- menopause, women, respiratory function, genitourinary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the relationship between genitourinary system symptoms and respiratory function and respiratory muscle strength in postmenopausal women.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in Postmenopausal Period | – | –All women who are postmenopausal and meet the participation criteria. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women who are postmenopausal and meet the participation criteria.
Key inclusion criteria (4 listed)
- being between 50-64 years of age,
- having passed menopause no more than eight years ago,
- having experienced at least one pregnancy,
- being literate;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Results publication: PubMed 38084782Kurne 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.
- Results publication: PubMed 36304000Sarmento 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu ŞAHİN, PT, PhD. principal investigator
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Halic 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 4 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 16 Jun 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?
Bristol Female Lower Urinary Tract Symptoms Index (BUTSI) (time frame: at baseline). The study lists 4 primary outcomes in all. 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 NCT07651566, which also lists 2 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 16 Jun 2026.