Effect of Mobile Application on Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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

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Urinary Incontinence,Stress Urinary Incontinence, Urge Urinary Incontinence, Mixed Symptoms Kegel Exercises Health, Subjective Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

In the study, participants will be left unaware of whether they are in the study or control group (single-blind masking).

Study Groups

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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.

Group Type EXPERIMENTAL

3 months follow-up

Intervention Type OTHER

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"

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence.

Intervention Type 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-up

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No