Quality of LifeNCT06093711
Urinary Incontinence in Married Women
An observational study of Quality of Life, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Description
- How many people
- 413 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2022to 20 Sep 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- over 18 years, married women, Those who agreed to participate in the research.
Who cannot join
- she wants to leave the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence, Type, And Risk Factors of Urinary Incontinence in Married Women and Its Effect on Their Quality of Life
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.
Read the detailed description
Urinary incontinence (UI) is involuntary urinary leakage. This condition causes physical, psycho-social, and economic problems.1 It is more prevalent in women than in men. It occurs in women during pregnancy, childbirth, or menopause. It can also be triggered by factors such as advanced age, diabetes mellitus, chronic urinary infections, hysterectomy, and obesity.2,3 While urinary incontinence is not a life-threatening condition, it significantly impacts the quality of life for women. It leads to social phobia, social isolation, reduced self-confidence and self-esteem, embarrassment, psychological issues, as well as individual and societal costs.2-4 Urinary incontinence represents a growing burden in numerous countries.5 (Milsom et al., 2014).
Urinary incontinence constitutes a significant public health issue when considering the global female population, their participation in the workforce, and their role in social life.6 Urinary incontinence afflicts more than 40% of women worldwide.7 (Liu et al., 2014). The prevalence of UI is 48.3%, 46.4%, 31.9%, and 18.7% in women over 18 years of age living in Germany, Denmark, China, and Norway, respectively.8-10 The prevalence of UI is 23.6% in women aged 45-60 years living in Brazil.11 The prevalence of UI ranges from 16.4% and 49.7 in Turkish women.12 The projected number of women with UI in the United States is expected to reach 28.4 million by 2050.13 Investigators believe that the prevalence of UI may be underestimated because many women either seek healthcare assistance late or not at all due to perceiving it as a natural consequence of aging or childbirth or because they feel embarrassed about the issue. Furthermore, only a small fraction of women who are diagnosed with UI receive effective treatment.2,3,14 More than half of women with UI (66.4%) take approximately three years to seek medical assistance due to fears of stigmatization and a lack of information about treatment.4,15 The treatment and care for UI necessitate a multidisciplinary approach due to the complexity of the condition and the various issues it involves. However, before women are willing to seek medical assistance for UI, they must first recognize it as a medical issue. Hence, it is essential to develop a comprehensive understanding of UI, raise awareness among women about the condition, and provide ongoing support for those affected by it. By taking these steps, we can effectively manage and prevent this condition, as well as create opportunities for early diagnosis and treatment. Therefore, this study investigated the prevalence, type, and risk factors of UI in married women and its effect on their quality of life.
- Conditions
- Quality of Life
- Being tested
- Description
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: October 2022 and July 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start5 Oct 2022
- Primary completion5 Jul 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHİNUR DURMUŞ İSKENDER, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093711
- Sponsor's protocol ID
- MDURMUSISKENDER
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence, Type, And Risk Factors of Urinary Incontinence in Married Women and Its Effect on Their Quality of Life
- ClinicalTrials.gov ID
- NCT06093711
- Acronym / sponsor ID
- MDURMUSISKENDER
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 23 Oct 2023 (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.
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.
Detailed description
Urinary incontinence (UI) is involuntary urinary leakage. This condition causes physical, psycho-social, and economic problems.1 It is more prevalent in women than in men. It occurs in women during pregnancy, childbirth, or menopause. It can also be triggered by factors such as advanced age, diabetes mellitus, chronic urinary infections, hysterectomy, and obesity.2,3 While urinary incontinence is not a life-threatening condition, it significantly impacts the quality of life for women. It leads to social phobia, social isolation, reduced self-confidence and self-esteem, embarrassment, psychological issues, as well as individual and societal costs.2-4 Urinary incontinence represents a growing burden in numerous countries.5 (Milsom et al., 2014).
Urinary incontinence constitutes a significant public health issue when considering the global female population, their participation in the workforce, and their role in social life.6 Urinary incontinence afflicts more than 40% of women worldwide.7 (Liu et al., 2014). The prevalence of UI is 48.3%, 46.4%, 31.9%, and 18.7% in women over 18 years of age living in Germany, Denmark, China, and Norway, respectively.8-10 The prevalence of UI is 23.6% in women aged 45-60 years living in Brazil.11 The prevalence of UI ranges from 16.4% and 49.7 in Turkish women.12 The projected number of women with UI in the United States is expected to reach 28.4 million by 2050.13 Investigators believe that the prevalence of UI may be underestimated because many women either seek healthcare assistance late or not at all due to perceiving it as a natural consequence of aging or childbirth or because they feel embarrassed about the issue. Furthermore, only a small fraction of women who are diagnosed with UI receive effective treatment.2,3,14 More than half of women with UI (66.4%) take approximately three years to seek medical assistance due to fears of stigmatization and a lack of information about treatment.4,15 The treatment and care for UI necessitate a multidisciplinary approach due to the complexity of the condition and the various issues it involves. However, before women are willing to seek medical assistance for UI, they must first recognize it as a medical issue. Hence, it is essential to develop a comprehensive understanding of UI, raise awareness among women about the condition, and provide ongoing support for those affected by it. By taking these steps, we can effectively manage and prevent this condition, as well as create opportunities for early diagnosis and treatment. Therefore, this study investigated the prevalence, type, and risk factors of UI in married women and its effect on their quality of life.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- over 18 years, married women, Those who agreed to participate in the research.
Key exclusion criteria (1 listed)
- she wants to leave the research.
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 |
|---|---|---|
| DescriptionAll 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. | Diagnostic test | – |
Primary outcome
Incontinence Quality of Life
Time frame: October 2022 and July 2023
Incontinence Quality of Life The total score ranges from 22 to 110, with higher scores indicating a higher quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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 Quality of Life, run by Kastamonu 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 1 inclusion and 1 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 23 Oct 2023. 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?
Incontinence Quality of Life (time frame: October 2022 and July 2023). 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 23 Oct 2023.