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NCT Number: NCT07669922

Urban-Rural Comparison of Urinary Incontinence Impact in Women

This study will examine how urinary incontinence affects women's daily activities and quality of life in urban and rural areas. Urinary incontinence means unintentional urine leakage. It may affect activities such as exercise, household tasks, social participation, travel, emotional well-being, and daily routines.

Women aged 18 to 65 years who have experienced urinary incontinence during the past 3 months may be eligible to participate. Participants will complete questionnaires about their health, urinary symptoms, severity of urine leakage, daily activities, and quality of life. The assessment is expected to take approximately 20 minutes.

This is an observational study. No medication, exercise program, medical procedure, or other treatment will be provided. The study will compare questionnaire results between women living in urban and rural areas. The findings may help improve understanding of how living environment and personal factors are associated with the impact of urinary incontinence.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

Primary location

Lokman Hekim University, Ankara, Ankara

Ankara, 06510, Turkey (Türkiye)

About this study

Urinary incontinence is the involuntary leakage of urine and may negatively affect women's physical activities, household responsibilities, social participation, emotional well-being, and overall quality of life. The perceived impact of urinary incontinence may vary according to living environment, access to health services, socioeconomic conditions, cultural attitudes, and daily life demands.

This cross-sectional observational study aims to compare urinary incontinence severity, urinary incontinence-related quality of life, and the impact of urinary incontinence on daily activities among women living in urban and rural areas.

Women aged 18 to 65 years who report urinary incontinence within the previous 3 months will be recruited voluntarily. Participants currently receiving medical, surgical, or conservative treatment for urinary incontinence; using a urinary catheter; having communication or cooperation problems that prevent questionnaire completion; or having neurological conditions that may cause urinary incontinence will not be included.

Eligible participants will complete a sociodemographic information form, the Three Incontinence Questions, the Incontinence Severity Index, the International Consultation on Incontinence Questionnaire-Short Form, the Incontinence Impact Questionnaire-7, and the Incontinence Quality of Life Questionnaire. Data will be collected face-to-face in a private setting. No intervention, treatment, medication, exercise program, or invasive procedure will be administered.

The primary purpose is to determine whether urinary incontinence severity and its effects on daily activities and quality of life differ between women living in urban and rural areas. The study will also examine the relationship between urinary incontinence-related outcomes and sociodemographic factors, including age, education level, employment status, body mass index, chronic disease status, birth history, delivery type, income level, and menopausal status.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women aged 18 to 65 years.
  • Reported urinary incontinence, including any amount of involuntary urine leakage, within the previous 3 months, as determined by the Three Incontinence Questions.
  • Able to understand and complete the study questionnaires.
  • Provided written informed consent.

Exclusion criteria

  • Currently receiving medical, surgical, or conservative treatment for urinary incontinence.
  • Use of a urinary catheter or indwelling urinary device.
  • Communication, cognitive, or cooperation problems that prevent completion of the questionnaires.
  • Diagnosis of a neurological or chronic condition that may cause urinary incontinence, including multiple sclerosis, spinal cord injury, Alzheimer disease, or Parkinson disease.

Treatment and study plan

Observational Assessment

Other

Participants completed assessment forms and diaries. No intervention was administered.

Primary outcomes

  1. Urinary Incontinence Severity Assessed by the Incontinence Severity Index

    Time frame: Baseline (Day 1)

    Urinary incontinence severity will be assessed using the Incontinence Severity Index. The score is calculated by multiplying the frequency of urinary leakage by the amount of urine leakage. Scores range from 1 to 12 and are categorized as mild (1-2), moderate (3-6), severe (8-9), or very severe (12). Higher scores indicate greater urinary incontinence severity.

  2. Impact of Urinary Incontinence on Daily Activities Assessed by the Incontinence Impact Questionnaire-7

    Time frame: Baseline (Day 1)

    The impact of urinary incontinence on daily activities will be assessed using the Incontinence Impact Questionnaire-7. The questionnaire evaluates the effect of urinary incontinence on household tasks, physical activities, social activities, travel, and emotional well-being. Scores are converted to a 0 to 100 scale. Higher scores indicate a greater negative impact of urinary incontinence on daily activities.

  3. Urinary Incontinence-Related Quality of Life Assessed by the Incontinence Quality of Life Questionnaire

    Time frame: Baseline (Day 1)

    Urinary incontinence-related quality of life will be assessed using the Incontinence Quality of Life Questionnaire. The questionnaire includes 22 items scored on a 5-point Likert scale. Scores are transformed to a 0 to 100 scale. Higher scores indicate better urinary incontinence-related quality of life.

Secondary outcomes

  1. Urinary Incontinence Symptom Severity and Impact Assessed by the International Consultation on Incontinence Questionnaire-Short Form

    Time frame: Baseline (Day 1)

    Urinary incontinence symptom severity and perceived impact on daily life will be assessed using the International Consultation on Incontinence Questionnaire-Short Form. The total score ranges from 0 to 21 and is calculated from urinary leakage frequency, amount of leakage, and perceived impact on daily life. Higher scores indicate greater symptom severity and greater impact on quality of life.

  2. Association of Sociodemographic and Clinical Characteristics With Urinary Incontinence Outcomes

    Time frame: Baseline (Day 1)

    Sociodemographic and clinical characteristics, including age, body mass index, education level, employment status, income level, chronic disease status, birth history, delivery type, and menopausal status, will be recorded and examined in relation to urinary incontinence severity, daily activity impact, and quality of life.

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

Impact of Urinary Incontinence on Quality of Life and Daily Activities in Women: A Cross-Sectional Comparison Between Urban and Rural Areas

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

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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