Osteoporosis, PostmenopausalNCT06655701
Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis
An observational study of Osteoporosis, Postmenopausal, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women
Who may be able to join
- Postmenopausal women with DXA measurements performed within the last 6 months.
- Based on DXA measurements:
- Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).
- Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.
- Aged 50-75 years
Who cannot join
- Refusal to participate in the study.
- History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
- Presence of psychiatric disorders.
- Cognitive impairments.
- Use of medications that could affect the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, 34147
Büşra Şirin Ahısha, MD, (0212) 856 27 40, bsrn080@gmail.com
Büşra Şirin Ahısha, MD
About this study
Official title: Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction
The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.
Read the detailed description
One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- No intervention
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal osteoporosis | Postmenopausal osteoporosis is diagnosed using Dual-X-ray Absorptiometry (DXA), which measures bone mineral density (BMD) and provides a T-score. A T-score of -2.5 or lower confirms the diagnosis of osteoporosis. Receives: Diagnostic Test: No intervention | |
| Postmenopausal non-osteoporotic women | These women maintain normal bone mineral density (BMD) levels, typically assessed using Dual-X-ray Absorptiometry (DXA). A T-score above -1.0 is considered normal. Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Stress Urinary Incontinence:
Stress urinary incontinence (SUI) is the involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or lifting. In this study, the presence of SUI will be determined through a questionnaire that asks participants about symptoms and frequency of urine leakage during such activities.
Measured: 0 day
Incontinence Quality of Life Scale (I-QOL):
The I-QOL is a validated questionnaire that measures the impact of urinary incontinence on a patient's quality of life. It assesses how incontinence affects daily activities, social interactions, and emotional well-being. Higher scores indicate better quality of life, while lower scores suggest that incontinence has a more significant negative impact on the patient's day-to-day functioning.
Measured: 0 day
Skeletal Muscle Mass:
Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.
Measured: 0 day
Handgrip Strength
This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start15 Nov 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655701
- Sponsor's protocol ID
- BeylikduzuStateH8
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirin Ahisha B, Paker N, Kesiktas N, Ersoy S, Bugdayci ND, Ahisha YC. Stress urinary incontinence and sarcopenia in postmenopausal osteoporosis: the intersection of muscle loss and pelvic dysfunction. World J Urol. 2026 Apr 5;44(1):276. doi: 10.1007/s00345-026-06392-3.
PubMed 41935994
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction
- ClinicalTrials.gov ID
- NCT06655701
- Acronym / sponsor ID
- BeylikduzuStateH8
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 23 Oct 2024 (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 primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.
Detailed description
One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal osteoporosis | – | Diagnostic Test: No interventionPostmenopausal osteoporosis is diagnosed using Dual-X-ray Absorptiometry (DXA), which measures bone mineral density (BMD) and provides a T-score. A T-score of -2.5 or lower confirms the diagnosis of osteoporosis. |
| Postmenopausal non-osteoporotic women | – | Diagnostic Test: No interventionThese women maintain normal bone mineral density (BMD) levels, typically assessed using Dual-X-ray Absorptiometry (DXA). A T-score above -1.0 is considered normal. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (5 listed)
- Postmenopausal women with DXA measurements performed within the last 6 months.
- Based on DXA measurements:
- Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).
- Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.
- Aged 50-75 years
Key exclusion criteria (5 listed)
- Refusal to participate in the study.
- History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
- Presence of psychiatric disorders.
- Cognitive impairments.
- Use of medications that could affect the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Postmenopausal non-osteoporotic women, Postmenopausal osteoporosis |
Primary outcome
Presence of Stress Urinary Incontinence:
Time frame: 0 day
Stress urinary incontinence (SUI) is the involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or lifting. In this study, the presence of SUI will be determined through a questionnaire that asks participants about symptoms and frequency of urine leakage during such activities.
Incontinence Quality of Life Scale (I-QOL):
Time frame: 0 day
The I-QOL is a validated questionnaire that measures the impact of urinary incontinence on a patient's quality of life. It assesses how incontinence affects daily activities, social interactions, and emotional well-being. Higher scores indicate better quality of life, while lower scores suggest that incontinence has a more significant negative impact on the patient's day-to-day functioning.
Skeletal Muscle Mass:
Time frame: 0 day
Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.
Handgrip Strength
Time frame: 0 day
This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 41935994Sirin Ahisha B, Paker N, Kesiktas N, Ersoy S, Bugdayci ND, Ahisha YC. Stress urinary incontinence and sarcopenia in postmenopausal osteoporosis: the intersection of muscle loss and pelvic dysfunction. World J Urol. 2026 Apr 5;44(1):276. doi: 10.1007/s00345-026-06392-3.
- 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.
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 Osteoporosis, Postmenopausal, run by Beylikduzu State Hospital 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Şirin Ahısha, MD ((0212) 856 27 40, bsrn080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Stress Urinary Incontinence: (time frame: 0 day). 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 NCT06655701, which also lists 1 linked publication.
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 12 Dec 2024.