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Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis

NCT ID: NCT06655701

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-01-15

Brief Summary

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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

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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

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Osteoporosis, Postmenopausal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No intervention

Intervention Type 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.

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Interventions

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No intervention

No intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beylikduzu State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Busra Sirin

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beylikdüzü State Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Büşra Şirin Ahısha, MD

Role: CONTACT

Phone: (0212) 856 27 40

Email: [email protected]

Facility Contacts

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Büşra Şirin Ahısha, MD

Role: primary

Other Identifiers

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BeylikduzuStateH8

Identifier Type: -

Identifier Source: org_study_id