Urinary IncontinenceNCT07669922
Urban-Rural Comparison of Urinary Incontinence Impact in Women
An observational study of Urinary Incontinence, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Observational assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of self-identified women aged 18 to 65 years living in urban or rural areas who have experienced urinary incontinence within the previous 3 months. Participants will be recruited on a voluntary basis through direct contact, announcements, and snowball sampling. Women living in urban and rural areas will be enrolled in separate cohorts, with a planned total sample size of 100 participants (50 urban and 50 rural).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University, Ankara, Ankara
Ankara, Ankara, 06510
About this study
Official title: Impact of Urinary Incontinence on Quality of Life and Daily Activities in Women: A Cross-Sectional Comparison Between Urban and Rural Areas
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.
Read the detailed description
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.
- Conditions
- Urinary Incontinence
- Being tested
- Observational assessment
- Keywords
- Urinary Incontinence, Women's Health, Quality of Life, Urban Population, Rural Population
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
Participants completed assessment forms and diaries. No intervention was administered.
| Study group | Role | What they receive |
|---|---|---|
| Urban Women With Urinary Incontinence | Women aged 18 to 65 years who live in urban areas and report urinary incontinence within the previous 3 months. Participants will complete questionnaires assessing urinary incontinence severity, urinary symptom impact, daily activities, quality of life, and sociodemographic characteristics. No intervention or treatment will be administered. Receives: Other: Observational assessment | |
| Rural Women With Urinary Incontinence | Women aged 18 to 65 years who live in rural areas and report urinary incontinence within the previous 3 months. Participants will complete questionnaires assessing urinary incontinence severity, urinary symptom impact, daily activities, quality of life, and sociodemographic characteristics. No intervention or treatment will be administered. Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence Severity Assessed by the Incontinence Severity Index
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.
Measured: Baseline (Day 1)
Impact of Urinary Incontinence on Daily Activities Assessed by the Incontinence Impact Questionnaire-7
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.
Measured: Baseline (Day 1)
Urinary Incontinence-Related Quality of Life Assessed by the Incontinence Quality of Life Questionnaire
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.
Measured: Baseline (Day 1)
Secondary outcomes (2)
Urinary Incontinence Symptom Severity and Impact Assessed by the International Consultation on Incontinence Questionnaire-Short Form
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.
Measured: Baseline (Day 1)
Association of Sociodemographic and Clinical Characteristics With Urinary Incontinence Outcomes
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demet Öztürk, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669922
- Sponsor's protocol ID
- 2025355
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Urinary Incontinence on Quality of Life and Daily Activities in Women: A Cross-Sectional Comparison Between Urban and Rural Areas
- ClinicalTrials.gov ID
- NCT07669922
- Acronym / sponsor ID
- 2025355
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Women's Health, Quality of Life, Urban Population, Rural Population
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban Women With Urinary Incontinence | – | Other: Observational assessmentWomen aged 18 to 65 years who live in urban areas and report urinary incontinence within the previous 3 months. Participants will complete questionnaires assessing urinary incontinence severity, urinary symptom impact, daily activities, quality of life, and sociodemographic characteristics. No intervention or treatment will be administered. |
| Rural Women With Urinary Incontinence | – | Other: Observational assessmentWomen aged 18 to 65 years who live in rural areas and report urinary incontinence within the previous 3 months. Participants will complete questionnaires assessing urinary incontinence severity, urinary symptom impact, daily activities, quality of life, and sociodemographic characteristics. No intervention or treatment will be administered. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of self-identified women aged 18 to 65 years living in urban or rural areas who have experienced urinary incontinence within the previous 3 months. Participants will be recruited on a voluntary basis through direct contact, announcements, and snowball sampling. Women living in urban and rural areas will be enrolled in separate cohorts, with a planned total sample size of 100 participants (50 urban and 50 rural).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentParticipants completed assessment forms and diaries. No intervention was administered. | Other | Rural Women With Urinary Incontinence, Urban Women With Urinary Incontinence |
Primary outcome
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.
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.
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.
2 secondary outcomes
Urinary Incontinence Symptom Severity and Impact Assessed by the International Consultation on Incontinence Questionnaire-Short Form
Time frame: Baseline (Day 1)
Association of Sociodemographic and Clinical Characteristics With Urinary Incontinence Outcomes
Time frame: Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Lokman Hekim University 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Urinary Incontinence Severity Assessed by the Incontinence Severity Index (time frame: Baseline (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.