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NCT Number: NCT06655701

Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis

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.

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Key information

Conditions

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

Age range

50 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Şirin Ahısha, MD

CONTACT

[email protected]

(0212) 856 27 40

Büşra Şirin Ahısha, MD

PRINCIPAL_INVESTIGATOR

Fatma Nur Kesiktaş, Prof

SUB_INVESTIGATOR

Nazlı Derya Buğdaycı, Doc

SUB_INVESTIGATOR

Nurdan Paker, Prof

SUB_INVESTIGATOR

Yiğit Can Ahısha, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Diagnostic Test

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Handgrip Strength

    Time frame: 0 day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Şirin Ahısha, MD

CONTACT

[email protected]

(0212) 856 27 40

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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