Development and Validation of Pelvi-Fit App

Study Overview
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Brief Summary
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Urinary incontinence (UI) is defined as involuntary urinary leakage or inability to control urine. Various physiological changes during pregnancy, including collagen changes, hormonal changes, and increased uterine and fetal weight, contribute to the weakening of the pelvic floor muscles (PFMs) during pregnancy. Approximately, 42% of women experience their first UI during pregnancy, and up to 31% of parous women have UI. Women with persistent UI after delivery may continue to experience UI for another 12 years. Therefore, UI during pregnancy may be an essential risk factor for subsequent UI among women. This Study will result in a product called Pelvi-Fit app that will help patients to self-treat their Pelvic Floor disorders in a way that is approved by medical experts. It will allow the patient to train their pelvic floor muscles independently who are not able to get medical assistance due to being in remote areas or any other reason.

Detailed Description
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Literature suggests that UI is troublesome, affects women's quality of life physically, emotionally, spiritually, and financially. Those who experience it may resort to various methods to deal with the problem, including using pads or incontinence diapers and avoiding social situations because of embarrassment. However, many women do not seek help despite having UI symptoms because of the perception of UI as embarrassment to initiate a discussion about UI with their health care provider. Some are unaware of treatment availability, such as PFM training (PFMT), whereas others feel they should not disturb their health care provider as UI is a temporary issue. Developing a positive attitude is essential to enable people to change their behavior successfully. The use of persuasive technology (PT) in mHealth apps may support attitude and behavior change in users to adopt PFMT as part of their lifestyle. The pre-final version of Pevi-Fit app will be made in this study. The control group will receive the validated content-based treatment protocol of UI in descriptive form and the experiment group will receive the same treatment of UI through pre-final version of the Pelvi-Fit app. The results of both groups will be recorded and compared to assess the effectiveness of using technological methods in the treatment of patients with Urinary Incontinence

Official Title
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Development and Validation of the Pelvi-Fit App for Women With Urinary Incontinence.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Pelvi-Fit app Training
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females of child-bearing age up to 65 years of age having Urinary Incontinence. Females having Cognitive ability to use the Pelvi-Fit App, screened through MMSE tool (Average score >25). Exclusion Criteria Patients of neurological conditions; SCI, Stroke. Not friendly to use mobile apps.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a Pretest-Postest Design with parallel assignment of patients into two groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvi-Fit Group<br>The experiment group will receive the treatment protocol for urinary incontinence based on evidence-based protocol through the Pelvi-Fit app. | Other: Pelvi-Fit app Training<br>* This group will receive Pelvic Floor Muscle Strengthening exercises through software application.<br>|
| Other: Control<br>This group will receive the same treatment protocol in a descriptive form (non-app-based treatment) for urinary incontinence. | Other: Control<br>* This group will receive Pelvic Floor Muscle Strengthening exercises through instructions and pamphlets describing exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence Severity Index | The severity index is based on information about frequency (four levels) and amount of leakage (two or three levels). By multiplication, an index value (1-8 or 1-12) is reached. This index value is further categorized into a severity index of three or four levels. | Changes from Baseline to 8th week | 
| ICIQ-UI SF- Questionnaire | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) evaluates the severity of UI symptoms and their impact on health-related quality of life. When using the ICIQ-UI SF, a total ICIQ score with a range from 0-21 is achieved from the first three questions. The (ICIQ-UISF) is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (Qu) of urinary incontinence in men and women in research and clinical practice across the world. It is scored on a scale from 0-21. | Changes from Baseline to 8th week |