NCT07669922

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 25, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

June 21, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

Urinary IncontinenceWomen's HealthQuality of LifeUrban PopulationRural Population

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline (Day 1)

Secondary Outcomes (2)

  • Urinary Incontinence Symptom Severity and Impact Assessed by the International Consultation on Incontinence Questionnaire-Short Form

    Baseline (Day 1)

  • Association of Sociodemographic and Clinical Characteristics With Urinary Incontinence Outcomes

    Baseline (Day 1)

Study Arms (2)

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.

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.

Other: Observational assessment

Interventions

Participants completed assessment forms and diaries. No intervention was administered.

Rural Women With Urinary IncontinenceUrban Women With Urinary Incontinence

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 18 to 65 years who have experienced urinary incontinence within the previous 3 months are eligible to participate.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University, Ankara, Ankara

Ankara, Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

January 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations