Effect of Mobile Application on Urinary Incontinence

January 6, 2024 updated by: Pınar Duru, Eskisehir Osmangazi University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Odunpazarı
      • Eskişehir, Odunpazarı, Turkey, 26040
        • Eskişehir Osmangazi University Health Practice and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
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.
Other: 3 months follow-up
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).
Behavioral: 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.
Other: Control group
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.
Other: 3 months follow-up
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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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".
6th week
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".
12th week
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.
6th week
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.
12th week
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).
6th week
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).
12th week
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.
6th week
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.
12th week
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.
6th week
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.
12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pınar Duru, PhD, Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AliCicekli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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