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OpenTrials
Completed

NCT Number: NCT05909969

Development and Validation of Pelvi-Fit App

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-Hussain Miternity Clinic

Mianwali, Punjab Province, 42206, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvi-Fit app Training

Other

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

Control

Other

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

Primary outcomes

  1. Incontinence Severity Index

    Time frame: Changes from Baseline to 8th week

    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.

  2. ICIQ-UI SF- Questionnaire

    Time frame: Changes from Baseline to 8th week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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