Clinical trial NCT05404386: Effect of Mobile Application on Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Incontinence,Stress
Urinary Incontinence, Urge
Urinary Incontinence, Mixed
Symptoms
Kegel Exercises
Health, Subjective
Quality of Life
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline urinary incontinence severity at 6 weeks
timeFrame: 6th week
measure: Change from baseline urinary incontinence severity at 12 weeks
timeFrame: 12th week
measure: Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 6 weeks
timeFrame: 6th week
measure: Change from the baseline level of urinary incontinence symptoms (frequency, amount, impact on daily life) at 12 weeks
timeFrame: 12th week
measure: Change from baseline Kegel exercise compliance level at 6 weeks
timeFrame: 6th week
measure: Change from baseline Kegel exercise compliance level at 12 weeks
timeFrame: 12th week
measure: Change from baseline urinary incontinence quality of life at 6 weeks
timeFrame: 6th week
measure: Change from baseline urinary incontinence quality of life at 12 weeks
timeFrame: 12th week
measure: Change from baseline health belief level for urinary incontinence and kegel exercise at 6 weeks
timeFrame: 6th week
measure: Change from baseline health belief level for urinary incontinence and kegel exercise at 12 weeks
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Health Practice and Research Hospital
state: Odunpazarı
Study officials:
affiliation: Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
name: Pınar Duru, PhD
role: PRINCIPAL_INVESTIGATOR
References: