Effect of Mobile Application on Urinary Incontinence

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05404386
• Other study ID #: AliCicekli
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Health Practice and Research Hospital	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	6th week
Primary	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".	12th week
Primary	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.	6th week
Primary	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.	12th week
Primary	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).	6th week
Primary	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).	12th week
Primary	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.	6th week
Primary	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.	12th week
Primary	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.	6th week
Primary	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.	12th week