NCT06093711

Brief Summary

Background: Urinary incontinence is involuntary urinary leakage. Although it is not life-threatening, it dramatically influences the quality of life. This study was conducted to determine the prevalence, type, and risk factors of UI in married women and its effect on their quality of life. Methods: This descriptive and cross-sectional study was conducted on 413 women. This research was conducted between October 2022 and July 2023 in the central district of a province in the northwestern region of Türkiye. The data were collected using a Personal Information Form and the Incontinence Quality of Life. The data were analyzed using the Statistical Package for Social Sciences (SPSS for Windows, IBM, version 22.0) at a significance level of 0.05. Descriptive statistics baseline characteristics. Normality was tested using the Kolmogorov-Smirnov test. The results showed that the data were normally distributed. Therefore, an independent t-test (t-table value) was used for two independent groups, while an Analysis of Variance (ANOVA) (F-table value) was used for more than two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 5, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 11, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incontinence Quality of Life

    Incontinence Quality of Life The total score ranges from 22 to 110, with higher scores indicating a higher quality of life.

    October 2022 and July 2023

Interventions

DescriptionDIAGNOSTIC_TEST

All patients were briefed about the research purpose and procedure. They were also informed about the following points: (1) participation is voluntary, (2) they can withdraw from the study at any stage without explanation, (3) the data will be used only for scientific purposes and will not be shared with third parties, and (4) they will remain anonymous throughout the research. Informed consent was obtained from those who agreed to participate. It took each participant 20-25 minutes to fill out the data collection tools.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMarried women will be included.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of all married women in the central district of a province in the northwestern region of Türkiye. The sample size was calculated using the formula for a known population. The results showed that a sample of 382 would be large enough to detect significant differences. The sample consisted of 413 women who agreed to participate in the study.

You may qualify if:

  • over 18 years, married women, Those who agreed to participate in the research.

You may not qualify if:

  • she wants to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Kastamonu, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

October 5, 2022

Primary Completion

July 5, 2023

Study Completion

September 20, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations