Urinary Incontinence,StressNCT05404386
Effect of Mobile Application on Urinary Incontinence
A study testing Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence., 3 months follow-up and Mobile application which named as "My Fighting with Incontinence" in people with Urinary Incontinence,Stress and Urinary Incontinence, Urge, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The first phase was designed in a methodological pattern in order to develop, usability, and performance of mobile application (mobileapp) called "My Fight with Incontinence". Aim of the second phase of the study was to evaluate the effect of mobileapp developed according to the health belief model on incontinence… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Mixed
- What is being tested?
- Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence., 3 months follow-up and Mobile application which named as "My Fighting with Incontinence"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the research
- Being a female
- Being in the age range of 18-65
- Using a smart mobile phone (for communicating via Whatsapp and installing a mobile application to the workgroup)
- BMI < 30kg/m2
- Being literate
- Having a diagnosis of urinary incontinence (stress, emergency/urge, mixed type)
Who cannot join
- Those who do not have an Android-based smartphone
- Have a physical or mental disability
- Those who have undergone vaginal and pelvic operations within 6 months
- Have given birth within 12 weeks
- Having a history of miscarriage within 6 weeks
- Those who have had recurrent vaginitis infections
- History of the cardiac implant or untreated cardiac arrhythmia
- Having a communication barrier
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Health Practice and Research Hospital
Eskişehir, Odunpazarı, 26040
About this study
Official title: The Effect of Mobile Application on Incontinence Symptoms, Compliance With Kegel Exercises, Health Belief, and Quality of Life of Women With Urinary Incontinence
The first phase was designed in a methodological pattern in order to develop, usability, and performance of mobile application (mobileapp) called "My Fight with Incontinence". Aim of the second phase of the study was to evaluate the effect of mobileapp developed according to the health belief model on incontinence symptoms, Kegel exercise compliance, health belief and quality of life towards UI and kegel exercises in women with UI. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 3-month follow-up period. The research will be carried out in the Urology service and polyclinics of Eskişehir Osmangazi University Health Practice and Research Hospital. The study population of the research consists of 203 female patients over the age of 18 who were followed up with the diagnosis of Stress, Urge, and Mixed Type UI. Sample selection will not be made in the first stage of the study, and mobileapp will be tested on people aged 18 and over who can be reached, working, studying, or receiving treatment at Eskişehir Osmangazi University Training, Application and Research Hospital and Eskişehir Osmangazi University. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 96 individuals, 48 in each group, with an increase of 20%, will form the research group. In the second stage of the study, "Incontinence Severity Index Questionnaire", "International Urinary Incontinence Inquiry Form-Short Form (ICIQ-SF)", "Kegel Exercise Compliance Follow-up Form", "Health Belief Scale for Urinary Incontinence and Kegel Exercise", "Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7)" will be used. Control group will be given a training booklet called "My Fight with Incontinence", which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to UI after the pre-tests are applied. After pre-tests are applied to the study group, "My Fight with Incontinence" mobileapp will be installed on their mobile phones by researcher. Reminders will be sent to the patients on a regular basis via the mobileapp. Participants in both the control and study groups will be provided with the link of the survey form created via google forms in the 6th and 12th weeks by sending an SMS.
Read the detailed description
Conservative, surgical, and pharmacological treatment methods are available in the treatment of urinary incontinence. Despite this, the first preferred method of treatment is the conservative treatment method. One of these methods and the most preferred one is pelvic floor muscle training (Kegel exercise). The reason why it is one of the most preferred treatment methods is that it is a reliable and effective method in reducing UI and increasing the quality of life. Research shows that mobile applications are effective in maintaining pelvic floor muscle exercise (Kegel exercise), improving quality of life, reducing urinary incontinence symptoms, accelerating the healing process, and facilitating access to care.
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Mixed, Symptoms, Kegel Exercises, Health, Subjective
- Being tested
- Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence., 3 months follow-up, Mobile application which named as "My Fighting with Incontinence"
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence.Other
After the participants enrolled in the study, a training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence will be given to the participants.
3 months follow-upOther
Follow-ups will be made 3 times in total, on the basis of pre-test (baseline), intermediate follow-up test (6th week), and post-test (12th week).
Mobile application which named as "My Fighting with Incontinence"Behavioural
The mobile application "My Fighting with Incontinence" aims to reduce incontinence symptoms of women with UI, ensure compliance with Kegel exercises, increase health belief and quality of life regarding UI and kegel exercises, and also allow researchers to be included in the awareness and management process.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study group intervention consists of a mobile application called "My Fight with Incontinence" structured according to the health belief model, and a 3-month follow-up. Receives: Other: 3 months follow-up; Behavioral: Mobile application which named as "My Fighting with Incontinence" |
| Control group | Other | In addition to routine care, control group intervention consists of the training booklet "My Fight with Incontinence" which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence, and a 3-month follow-up. Receives: Other: Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence.; Other: 3 months follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline urinary incontinence severity at 6 weeks
The severity of the complaint of urinary incontinence will be evaluated using the "Incontinence Severity Index (ISI) Questionnaire". The lowest "1" and the highest "12" points can be obtained from the questionnaire. Accordingly, 1-2 points are evaluated as "mild", 3-6 points as "moderate", 8-9 points as "severe" and 12 points as "very severe".
Measured: 6th week
Change from baseline urinary incontinence severity at 12 weeks
The severity of the complaint of urinary incontinence will be evaluated using the "Incontinence Severity Index (ISI) Questionnaire". The lowest "1" and the highest "12" points can be obtained from the questionnaire. Accordingly, 1-2 points are evaluated as "mild", 3-6 points as "moderate", 8-9 points as "severe" and 12 points as "very severe".
Measured: 12th week
Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 6 weeks
"International urinary incontinence inquiry form-short form (ICIQ-SF)" will be used to evaluate urinary incontinence-related incontinence symptoms or complaints and their effect on the quality of life. The scale consists of 6 questions in total and 4 sub-dimensions as "frequency of urinary incontinence", "amount of urinary incontinence", "effect of urinary incontinence in daily life" and "causes of urinary incontinence". A minimum of 0 and a maximum of 21 points can be obtained from the scale. A high score on the scale indicates that urinary incontinence has a great impact on quality of life.
Measured: 6th week
Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 12 weeks
"International urinary incontinence inquiry form-short form (ICIQ-SF)" will be used to evaluate urinary incontinence-related incontinence symptoms or complaints and their effect on the quality of life. The scale consists of 6 questions in total and 4 sub-dimensions as "frequency of urinary incontinence", "amount of urinary incontinence", "effect of urinary incontinence in daily life" and "causes of urinary incontinence". A minimum of 0 and a maximum of 21 points can be obtained from the scale. A high score on the scale indicates that urinary incontinence has a great impact on quality of life.
Measured: 12th week
Change from baseline Kegel exercise compliance level at 6 weeks
The patients' compliance with kegel exercises (frequency of doing kegel exercises) will be evaluated with the "Kegel exercise compliance follow-up form" created by the researchers, in which the patients can mark the exercise practice times (7 days a week, morning-lunch-evening).
Measured: 6th week
Change from baseline Kegel exercise compliance level at 12 weeks
The patients' compliance with kegel exercises (frequency of doing kegel exercises) will be evaluated with the "Kegel exercise compliance follow-up form" created by the researchers, in which the patients can mark the exercise practice times (7 days a week, morning-lunch-evening).
Measured: 12th week
Change from baseline urinary incontinence quality of life at 6 weeks
Urogenital distress inventory-6 (UDI-6) and Incontinence effect questionnaire-7 (IIQ-7) will be used to determine the quality of life of patients with urinary incontinence. A minimum of 0 and a maximum of 18 points can be obtained from UDI-6, and a minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score of both forms is calculated at over 100 points. Low scores indicate higher quality of life.
Measured: 6th week
Change from baseline urinary incontinence quality of life at 12 weeks
Urogenital distress inventory-6 (UDI-6) and Incontinence effect questionnaire-7 (IIQ-7) will be used to determine the quality of life of patients with urinary incontinence. A minimum of 0 and a maximum of 18 points can be obtained from UDI-6, and a minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score of both forms is calculated at over 100 points. Low scores indicate higher quality of life.
Measured: 12th week
Change from baseline health belief level for urinary incontinence and kegel exercise at 6 weeks
"Health belief scale for urinary incontinence and kegel exercise" will be used to determine the beliefs of individuals about urinary incontinence and kegel exercise. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions: "sensitivity", "seriousness", "health motivation", "kegel exercise benefit perception", "kegel exercise obstacle perception" and "self-efficacy". The scale does not have a total score. Sensitivity, seriousness, health motivation, kegel exercise benefit perception, and self-efficacy sub-dimensions are positive, while the kegel exercise obstacle perception sub-dimension is negative. Higher scores increase sensitivity, seriousness, and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Measured: 6th week
Change from baseline health belief level for urinary incontinence and kegel exercise at 12 weeks
"Health belief scale for urinary incontinence and kegel exercise" will be used to determine the beliefs of individuals about urinary incontinence and kegel exercise. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions: "sensitivity", "seriousness", "health motivation", "kegel exercise benefit perception", "kegel exercise obstacle perception" and "self-efficacy". The scale does not have a total score. Sensitivity, seriousness, health motivation, kegel exercise benefit perception, and self-efficacy sub-dimensions are positive, while the kegel exercise obstacle perception sub-dimension is negative. Higher scores increase sensitivity, seriousness, and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Sep 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Duru, Eskisehir Osmangazi University
- Investigators
- Pınar Duru, PhD, Principal investigator, Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404386
- Sponsor's protocol ID
- AliCicekli
- Status last verified
- Jan 2024
- First submitted
- 28 May 2022
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application on Incontinence Symptoms, Compliance With Kegel Exercises, Health Belief, and Quality of Life of Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05404386
- Acronym / sponsor ID
- AliCicekli
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Mixed, Symptoms, Kegel Exercises, Health, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 3 Jun 2022 (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.
The first phase was designed in a methodological pattern in order to develop, usability, and performance of mobile application (mobileapp) called "My Fight with Incontinence". Aim of the second phase of the study was to evaluate the effect of mobileapp developed according to the health belief model on incontinence symptoms, Kegel exercise compliance, health belief and quality of life towards UI and kegel exercises in women with UI. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 3-month follow-up period. The research will be carried out in the Urology service and polyclinics of Eskişehir Osmangazi University Health Practice and Research Hospital. The study population of the research consists of 203 female patients over the age of 18 who were followed up with the diagnosis of Stress, Urge, and Mixed Type UI. Sample selection will not be made in the first stage of the study, and mobileapp will be tested on people aged 18 and over who can be reached, working, studying, or receiving treatment at Eskişehir Osmangazi University Training, Application and Research Hospital and Eskişehir Osmangazi University. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 96 individuals, 48 in each group, with an increase of 20%, will form the research group. In the second stage of the study, "Incontinence Severity Index Questionnaire", "International Urinary Incontinence Inquiry Form-Short Form (ICIQ-SF)", "Kegel Exercise Compliance Follow-up Form", "Health Belief Scale for Urinary Incontinence and Kegel Exercise", "Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7)" will be used. Control group will be given a training booklet called "My Fight with Incontinence", which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to UI after the pre-tests are applied. After pre-tests are applied to the study group, "My Fight with Incontinence" mobileapp will be installed on their mobile phones by researcher. Reminders will be sent to the patients on a regular basis via the mobileapp. Participants in both the control and study groups will be provided with the link of the survey form created via google forms in the 6th and 12th weeks by sending an SMS.
Detailed description
Conservative, surgical, and pharmacological treatment methods are available in the treatment of urinary incontinence. Despite this, the first preferred method of treatment is the conservative treatment method. One of these methods and the most preferred one is pelvic floor muscle training (Kegel exercise). The reason why it is one of the most preferred treatment methods is that it is a reliable and effective method in reducing UI and increasing the quality of life. Research shows that mobile applications are effective in maintaining pelvic floor muscle exercise (Kegel exercise), improving quality of life, reducing urinary incontinence symptoms, accelerating the healing process, and facilitating access to care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: 3 months follow-up, Behavioral: Mobile application which named as "My Fighting with Incontinence"Study group intervention consists of a mobile application called "My Fight with Incontinence" structured according to the health belief model, and a 3-month follow-up. |
| Control group | Other | Other: Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence., Other: 3 months follow-upIn addition to routine care, control group intervention consists of the training booklet "My Fight with Incontinence" which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence, and a 3-month follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in the research
- Being a female
- Being in the age range of 18-65
- Using a smart mobile phone (for communicating via Whatsapp and installing a mobile application to the workgroup)
- BMI < 30kg/m2
Key exclusion criteria (8 listed)
- Those who do not have an Android-based smartphone
- Have a physical or mental disability
- Those who have undergone vaginal and pelvic operations within 6 months
- Have given birth within 12 weeks
- Having a history of miscarriage within 6 weeks
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 |
|---|---|---|
| Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence.After the participants enrolled in the study, a training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence will be given to the participants. | Other | Control group |
| 3 months follow-upFollow-ups will be made 3 times in total, on the basis of pre-test (baseline), intermediate follow-up test (6th week), and post-test (12th week). | Other | Control group, Study group |
| Mobile application which named as "My Fighting with Incontinence"The mobile application "My Fighting with Incontinence" aims to reduce incontinence symptoms of women with UI, ensure compliance with Kegel exercises, increase health belief and quality of life regarding UI and kegel exercises, and also allow researchers to be included in the awareness and management process. | Behavioural | Study group |
Primary outcome
Change from baseline urinary incontinence severity at 6 weeks
Time frame: 6th week
The severity of the complaint of urinary incontinence will be evaluated using the "Incontinence Severity Index (ISI) Questionnaire". The lowest "1" and the highest "12" points can be obtained from the questionnaire. Accordingly, 1-2 points are evaluated as "mild", 3-6 points as "moderate", 8-9 points as "severe" and 12 points as "very severe".
Change from baseline urinary incontinence severity at 12 weeks
Time frame: 12th week
The severity of the complaint of urinary incontinence will be evaluated using the "Incontinence Severity Index (ISI) Questionnaire". The lowest "1" and the highest "12" points can be obtained from the questionnaire. Accordingly, 1-2 points are evaluated as "mild", 3-6 points as "moderate", 8-9 points as "severe" and 12 points as "very severe".
Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 6 weeks
Time frame: 6th week
"International urinary incontinence inquiry form-short form (ICIQ-SF)" will be used to evaluate urinary incontinence-related incontinence symptoms or complaints and their effect on the quality of life. The scale consists of 6 questions in total and 4 sub-dimensions as "frequency of urinary incontinence", "amount of urinary incontinence", "effect of urinary incontinence in daily life" and "causes of urinary incontinence". A minimum of 0 and a maximum of 21 points can be obtained from the scale. A high score on the scale indicates that urinary incontinence has a great impact on quality of life.
Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 12 weeks
Time frame: 12th week
"International urinary incontinence inquiry form-short form (ICIQ-SF)" will be used to evaluate urinary incontinence-related incontinence symptoms or complaints and their effect on the quality of life. The scale consists of 6 questions in total and 4 sub-dimensions as "frequency of urinary incontinence", "amount of urinary incontinence", "effect of urinary incontinence in daily life" and "causes of urinary incontinence". A minimum of 0 and a maximum of 21 points can be obtained from the scale. A high score on the scale indicates that urinary incontinence has a great impact on quality of life.
Change from baseline Kegel exercise compliance level at 6 weeks
Time frame: 6th week
The patients' compliance with kegel exercises (frequency of doing kegel exercises) will be evaluated with the "Kegel exercise compliance follow-up form" created by the researchers, in which the patients can mark the exercise practice times (7 days a week, morning-lunch-evening).
Change from baseline Kegel exercise compliance level at 12 weeks
Time frame: 12th week
The patients' compliance with kegel exercises (frequency of doing kegel exercises) will be evaluated with the "Kegel exercise compliance follow-up form" created by the researchers, in which the patients can mark the exercise practice times (7 days a week, morning-lunch-evening).
Change from baseline urinary incontinence quality of life at 6 weeks
Time frame: 6th week
Urogenital distress inventory-6 (UDI-6) and Incontinence effect questionnaire-7 (IIQ-7) will be used to determine the quality of life of patients with urinary incontinence. A minimum of 0 and a maximum of 18 points can be obtained from UDI-6, and a minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score of both forms is calculated at over 100 points. Low scores indicate higher quality of life.
Change from baseline urinary incontinence quality of life at 12 weeks
Time frame: 12th week
Urogenital distress inventory-6 (UDI-6) and Incontinence effect questionnaire-7 (IIQ-7) will be used to determine the quality of life of patients with urinary incontinence. A minimum of 0 and a maximum of 18 points can be obtained from UDI-6, and a minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score of both forms is calculated at over 100 points. Low scores indicate higher quality of life.
Change from baseline health belief level for urinary incontinence and kegel exercise at 6 weeks
Time frame: 6th week
"Health belief scale for urinary incontinence and kegel exercise" will be used to determine the beliefs of individuals about urinary incontinence and kegel exercise. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions: "sensitivity", "seriousness", "health motivation", "kegel exercise benefit perception", "kegel exercise obstacle perception" and "self-efficacy". The scale does not have a total score. Sensitivity, seriousness, health motivation, kegel exercise benefit perception, and self-efficacy sub-dimensions are positive, while the kegel exercise obstacle perception sub-dimension is negative. Higher scores increase sensitivity, seriousness, and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Change from baseline health belief level for urinary incontinence and kegel exercise at 12 weeks
Time frame: 12th week
"Health belief scale for urinary incontinence and kegel exercise" will be used to determine the beliefs of individuals about urinary incontinence and kegel exercise. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions: "sensitivity", "seriousness", "health motivation", "kegel exercise benefit perception", "kegel exercise obstacle perception" and "self-efficacy". The scale does not have a total score. Sensitivity, seriousness, health motivation, kegel exercise benefit perception, and self-efficacy sub-dimensions are positive, while the kegel exercise obstacle perception sub-dimension is negative. Higher scores increase sensitivity, seriousness, and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- 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.
Pınar Duru, PhD principal investigator
Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence., 3 months follow-up and Mobile application which named as "My Fighting with Incontinence" in people with Urinary Incontinence,Stress and Urinary Incontinence, Urge, run by Eskisehir Osmangazi 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 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. 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?
Results are not available in the source record.
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?
Change from baseline urinary incontinence severity at 6 weeks (time frame: 6th week). The study lists 10 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 9 Jan 2024.