Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis

NCT06655701 | Recruiting

• 1 other identifier: BeylikduzuStateH8
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  0 day

• Handgrip Strength

  This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.

  0 day

Study Arms (2)

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.

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.

Diagnostic Test: No intervention

Interventions

No intervention DIAGNOSTIC_TEST

No intervention

Postmenopausal non-osteoporotic women; Postmenopausal osteoporosis

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Büşra Şirin Ahısha, MD

CONTACT

(0212) 856 27 40; bsrn080@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)