Development and Validation of Pelvi-Fit App

NCT ID: NCT05909969

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2023-12-31

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

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pelvi-Fit Group

The experiment group will receive the treatment protocol for urinary incontinence based on evidence-based protocol through the Pelvi-Fit app.

Group Type: EXPERIMENTAL

Pelvi-Fit app Training

Intervention Type: OTHER

This group will receive Pelvic Floor Muscle Strengthening exercises through software application.

Control

This group will receive the same treatment protocol in a descriptive form (non-app-based treatment) for urinary incontinence.

Group Type: OTHER

Control

Intervention Type: OTHER

This group will receive Pelvic Floor Muscle Strengthening exercises through instructions and pamphlets describing exercises.

Interventions

Pelvi-Fit app Training

This group will receive Pelvic Floor Muscle Strengthening exercises through software application.

Intervention Type: OTHER

Control

This group will receive Pelvic Floor Muscle Strengthening exercises through instructions and pamphlets describing exercises.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Riaz, PHD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Al-Hussain Miternity Clinic

Mianwali, Punjab Province, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 35090464 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 40997686 (View on PubMed)

Other Identifiers

RiphahIU Yusra Niazi

Identifier Type: -

Identifier Source: org_study_id