跳至主要内容
临床试验/NCT07383987
NCT07383987
招募中
不适用

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

Gulhane School of Medicine1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2025年12月1日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Gulhane School of Medicine
入组人数
246
试验地点
1
主要终点
Bristol Female Lower Urinary Tract Symptoms Questionnaire

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Normal Weight Group

Normal Weight Group: This group consists of female participants aged 18-45 years with a Body Mass Index (BMI) ranging from 18.5 to 24.9 kg/m². These individuals serve as the control group to evaluate baseline genital hygiene habits, toilet behaviors, body awareness, and lower urinary tract symptoms.

Overweight Group

Overweight Group: This group consists of female participants aged 18-45 years with a Body Mass Index (BMI) ranging from 25.0 to 29.9 kg/m². This group is evaluated to determine the specific impact of being overweight on urogenital health and behavioral factors compared to normal-weight and obese individuals.

Obese Group

Obese Group: This group consists of female participants aged 18-45 years with a Body Mass Index (BMI) of 30.0 kg/m² or higher. This group is evaluated to investigate how obesity correlates with the severity of lower urinary tract symptoms, genital hygiene practices, and body awareness levels.

结局指标

主要结局

Bristol Female Lower Urinary Tract Symptoms Questionnaire

时间窗: 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.

Genital Hygiene Behaviour Scale

时间窗: 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.

Toilet Behaviors - Women's Elimination Behaviors Scale

时间窗: 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.

Body Awareness Questionnare

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Gulhane School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Çoban

Assistant Professor

Gulhane School of Medicine

研究点 (1)

Loading locations...

相似试验