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Completed

NCT Number: NCT07383987

Genital Hygiene, Toilet Behaviors, and LUTS in Normal Weight and Obese Women

The aim of this study is to evaluate and compare genital hygiene habits, toilet behaviors, body awareness levels, and lower urinary tract symptoms (LUTS) in women aged 18-45 years, categorized by Body Mass Index (BMI) as normal weight (BMI = 18.5-24.9 kg/m²) and overweight/obese (BMI ≥ 25 kg/m²). The study seeks to improve social participation and quality of life by increasing awareness regarding obesity, genital hygiene, and urogenital health.

H1: There is a significant difference in lower urinary tract symptoms between BMI groups.

H2: There is a significant difference in genital hygiene behaviors between BMI groups.

H3: There is a significant difference in toilet behaviors between BMI groups. H4: There is a significant difference in body awareness levels between BMI groups.

H5: There is a significant relationship between lower urinary tract symptoms and genital hygiene behavior.

H6: There is a significant relationship between lower urinary tract symptoms and toilet behavior.

H7: There is a significant relationship between lower urinary tract symptoms and body awareness.

H8: There is a significant relationship between genital hygiene behavior and body awareness.

H9: There is a significant relationship between toilet behavior and body awareness.

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Key information

About this study

While existing literature often focuses on single variables, this research adopts a holistic approach. The findings will help clarify the behavioral and awareness-related factors underlying the increased risk of LUTS and infections in overweight/obese women. Ultimately, this study aims to contribute to the development of weight-specific preventive strategies to protect women's urogenital health.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female participants
  • Between the ages of 18 and 45
  • Body mass index (BMI) between 18.5-24.9 kg/m² for the normal weight group
  • Body mass index (BMI) ≥ 25 kg/m² for the overweight/obese group
  • Sufficient cognitive function to answer the questionnaires
  • Not having entered menopause

Exclusion criteria

  • Being pregnant or breastfeeding
  • History of bariatric surgery
  • History of gynecological or urological surgery/operation
  • Diagnosis of lower urinary tract infection or presence of active infection -symptoms
  • Presence of any neurological disease
  • Presence of any psychiatric disease
  • Presence of any oncological disease
  • Presence of a communication disorder that would interfere with the questionnaire application

Treatment and study plan

Primary outcomes

  1. Bristol Female Lower Urinary Tract Symptoms Questionnaire

    Time frame: Baseline (Single assessment at study enrollment)

    The Bristol Female Lower Urinary Tract Symptoms Questionnaire to assess incontinence and other LUTS, sexual health, and quality of life, has a Cronbach's alpha coefficient of 0.78. In the Turkish version's validity and reliability study conducted by Gökkaya et al., the Cronbach's alpha coefficient was found to be 0.931. The Bristol Female Lower Urinary Tract Symptoms questionnaire consists of 19 questions in 5 subscales: storage (questions 1-4), voiding (questions 5-7), incontinence (questions 8-12), sexual life (questions 13-14), and quality of life (questions 15-19). Questions) and has a Likert-type scoring system ranging from 0 to 3 points for questions 4, 13, 14, 17, and 19, and from 0 to 4 points for the others. A high score indicates increased LUTS severity and a negative impact on quality of life and sexual life.

  2. Genital Hygiene Behaviour Scale

    Time frame: Baseline (Single assessment at study enrollment)

    The Genital Hygiene Practices Scale is a five-point Likert-type scale completed by women themselves, consisting of a total of 23 items and 3 subscales. The subscales of the scale are: 'General Hygiene Habits (first 12 items)', 'Menstrual Hygiene (items 13-20)', and 'Awareness of Abnormal Findings (items 21-23). Scale items are scored numerically from 5 to 1, ranging from 'strongly agree' to 'strongly disagree'. The scale ranges from a minimum score of 23 to a maximum score of 115, with items 7, 14, 19, 20, and 23 being reverse-scored. Higher scores on the scale indicate positive genital hygiene behavior.

  3. Toilet Behaviors - Women's Elimination Behaviors Scale

    Time frame: Baseline (Single assessment at study enrollment)

    The Toilet Behavior-Female Voiding Behavior Scale consists of 18 questions. The Turkish version of the scale consists of 15 questions. The Urination Behavior Scale for Women consists of subgroups such as preferred location for urination (2 items), early urination (4 items), delaying urination (3 items), difficulty urinating (4 items), preferred position for urination (2 items), and each item is scored as 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The internal consistency and reliability of the five subgroups range from 0.70 to 0.88, and the Cronbach's alpha coefficient is 0.81.

  4. Body Awareness Questionnare

    Time frame: Baseline (Single assessment at study enrollment)

    The Body Awareness Questionnaire is an 18-item measure that assesses an individual's reported sensitivity to bodily processes and their ability to predict bodily responses. The Body Awareness Questionnaire has four subscales: 'prediction of bodily responses', 'sleep-wake cycle', 'prediction at the onset of illness', and 'attention to changes and responses in bodily processes', and a 7-point Likert scale is used for evaluation. In this scale, responses are rated from 1 (does not describe me at all) to 7 (describes me completely), and the total score is obtained by adding up the scores for each item. The higher the total score, the higher the body awareness.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

Investigation of Genital Hygiene, Toilet Behaviors, Body Awareness, and Lower Urinary Tract Symptoms in Normal Weight and Overweight/Obese Women

Acronym: GH-TB-BA-LUTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
May 22, 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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