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Lower Urinary Tract Symptoms (LUTS)GH-TB-BA-LUTSNCT07383987

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

An observational study of Lower Urinary Tract Symptoms (LUTS) and Genital Hygiene, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
How many people
216 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 15 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: The study will be conducted on women of normal weight, overweight, and obese women. Snowball sampling will be used to collect data from women of normal weight and overweight women. Data on obese women will be collected from women who apply to the Ankara Etlik City Hospital General Hospital Obesity Center and are selected based on our criteria.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Etlik City Hospital

    Ankara, KEÇİÖREN, 06000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Keywords
obesity, lower urinary tract symptoms, toileting behaviour, genital hygiene behaviours, body awareness
Medical subject headings
Lower Urinary Tract Symptoms, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07383987
Study groupRoleWhat they receive
Normal Weight GroupNormal 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 GroupOverweight 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 GroupObese 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bristol Female Lower Urinary Tract Symptoms Questionnaire

    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.

    Measured: Baseline (Single assessment at study enrollment)

  2. Genital Hygiene Behaviour Scale

    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.

    Measured: Baseline (Single assessment at study enrollment)

  3. Toilet Behaviors - Women's Elimination Behaviors Scale

    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.

    Measured: Baseline (Single assessment at study enrollment)

  4. Body Awareness Questionnare

    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.

    Measured: Baseline (Single assessment at study enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start1 Dec 2025
  3. Primary completion15 Mar 2026
  4. Study completion15 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07383987
Sponsor's protocol ID
2025-035
Acronym
GH-TB-BA-LUTS
Status last verified
Nov 2025
First submitted
26 Jan 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35498154
  • 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.

    PubMed 39272085
  • 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.

    PubMed 37886637
  • 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.

  • 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.

    PubMed 21522032
  • Karahan, N., Development of "Genital Hygiene Behaviours Scale": Study of Validity and Reliability. 2017. 18(3): p. 0-0.

  • 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.

    PubMed 25741223
  • 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.

  • 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.

    PubMed 8705212

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Symptoms (LUTS) and Genital Hygiene, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bristol Female Lower Urinary Tract Symptoms Questionnaire (time frame: Baseline (Single assessment at study enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07383987, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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