Clinical trial NCT05909969: Development and Validation of Pelvi-Fit App
Official title: Development and Validation of the Pelvi-Fit App for Women With Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a Pretest-Postest Design with parallel assignment of patients into two groups.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Incontinence Severity Index
timeFrame: Changes from Baseline to 8th week
measure: ICIQ-UI SF- Questionnaire
timeFrame: Changes from Baseline to 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Mianwali
country: Pakistan
facility: Al-Hussain Miternity Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jaffar A, Tan CE, Mohd-Sidik S, Admodisastro N, Goodyear-Smith F. Persuasive Technology in an mHealth App Designed for Pelvic Floor Muscle Training Among Women: Systematic Review. JMIR Mhealth Uhealth. 2022 Mar 22;10(3):e28751. doi: 10.2196/28751.
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