- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383987
Genital Hygiene, Toilet Behaviors, and LUTS in Normal Weight and Obese Women (GH-TB-BA-LUTS)
Investigation of Genital Hygiene, Toilet Behaviors, Body Awareness, and Lower Urinary Tract Symptoms in Normal Weight and Overweight/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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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KEÇİÖREN
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Ankara, KEÇİÖREN, Turkey (Türkiye), 06000
- Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Bristol Female Lower Urinary Tract Symptoms Questionnaire
Time Frame: Baseline (Single assessment at study enrollment)
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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.
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Baseline (Single assessment at study enrollment)
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Genital Hygiene Behaviour Scale
Time Frame: Baseline (Single assessment at study enrollment)
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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.
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Baseline (Single assessment at study enrollment)
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Toilet Behaviors - Women's Elimination Behaviors Scale
Time Frame: Baseline (Single assessment at study enrollment)
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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.
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Baseline (Single assessment at study enrollment)
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Body Awareness Questionnare
Time Frame: Baseline (Single assessment at study enrollment)
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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.
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Baseline (Single assessment at study enrollment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özge ÖZKUTLU, Assistant Professor, Department of Physiotherapy and Rehabilitation, Faculty of Physiotherapy and Rehabilitation, University of Health Sciences
Publications and helpful links
General Publications
- Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.
- Khalaf KM, Coyne KS, Globe DR, Armstrong EP, Malone DC, Burks J. Lower urinary tract symptom prevalence and management among patients with multiple sclerosis. Int J MS Care. 2015 Jan-Feb;17(1):14-25. doi: 10.7224/1537-2073.2013-040.
- Karaca, S. and B. Bayar, TURKISH VERSION OF BODY AWARENESS QUESTIONNAIRE: VALIDITY AND RELIABILITY STUDY. Türk Fizyoterapi ve Rehabilitasyon Dergisi, 2021. 32(1): p. 44-50.
- Shields, S., M. Mallory, and A. Simon, The Body Awareness Questionnaire: Reliability and Validity. Journal of Personality Assessment - J PERSONAL ASSESS, 1989. 53: p. 802-815.
- seyhan ak, E., et al., Tuvalet Davranışı-Kadınların Boşaltım Davranışları Ölçeğinin Türkçe'ye Uyarlanması: Geçerlik ve Güvenirlik Çalışması. Turkiye Klinikleri Journal of Nursing Sciences, 2019. 11.
- Karahan, N., Development of "Genital Hygiene Behaviours Scale": Study of Validity and Reliability. 2017. 18(3): p. 0-0.
- Gökkaya, C., et al., Validation of Turkish Version of Bristol Female Lower Urinary Tract Symptom Index. Journal of Clinical and Analytical Medicine, 2012. 3: p. 415-418.
- Newman DK, Burgio KL, Cain C, Hebert-Beirne J, Low LK, Palmer MH, Smith AL, Rickey L, Rudser K, Gahagan S, Harlow BL, James AS, Lacoursiere DY, Hardacker CT, Wyman JF; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Toileting Behaviors and Lower Urinary Tract Symptoms: A Cross-sectional Study of Diverse Women in the United States. Int J Nurs Stud Adv. 2021 Nov;3:100052. doi: 10.1016/j.ijnsa.2021.100052. Epub 2021 Nov 10.
- Amous Y, Isefan S, Hamarsheh K, Hijaz H, Amer R, Shawahna R. Lower urinary tract symptoms among normal-weight, overweight, and obese palestinians: a study of prevalence and impact on the quality of life. BMC Urol. 2024 Sep 13;24(1):199. doi: 10.1186/s12894-024-01587-5.
- Shang X, Fu Y, Jin X, Wang C, Wang P, Guo P, Wang Y, Yan S. Association of overweight, obesity and risk of urinary incontinence in middle-aged and older women: a meta epidemiology study. Front Endocrinol (Lausanne). 2023 Oct 10;14:1220551. doi: 10.3389/fendo.2023.1220551. eCollection 2023.
- Wang K, Palmer MH. Development and validation of an instrument to assess women's toileting behavior related to urinary elimination: preliminary results. Nurs Res. 2011 May-Jun;60(3):158-64. doi: 10.1097/NNR.0b013e3182159cc7.
Helpful Links
- Lower urinary tract symptoms among normal-weight, overweight, and obese palestinians: a study of prevalence and impact on the quality of life.
- Toileting Behaviors and Lower Urinary Tract Symptoms: A Cross-sectional Study of Diverse Women in the United States
- Association of overweight, obesity and risk of urinary incontinence in middle-aged and older women: a meta epidemiology study. 2023.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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