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Development and Validation of Pelvi-Fit App

Primary Purpose

Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvi-Fit app Training
Control
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Pelvi-Fit Group

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2023
    Last Updated
    July 7, 2023
    Sponsor
    Riphah International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05909969
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 12, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Riphah International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This will be a Pretest-Postest Design with parallel assignment of patients into two groups.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pelvi-Fit Group
    Arm Type
    Experimental
    Arm Description
    The experiment group will receive the treatment protocol for urinary incontinence based on evidence-based protocol through the Pelvi-Fit app.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    This group will receive the same treatment protocol in a descriptive form (non-app-based treatment) for urinary incontinence.
    Intervention Type
    Other
    Intervention Name(s)
    Pelvi-Fit app Training
    Intervention Description
    This group will receive Pelvic Floor Muscle Strengthening exercises through software application.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    This group will receive Pelvic Floor Muscle Strengthening exercises through instructions and pamphlets describing exercises.
    Primary Outcome Measure Information:
    Title
    Incontinence Severity Index
    Description
    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.
    Time Frame
    Changes from Baseline to 8th week
    Title
    ICIQ-UI SF- Questionnaire
    Description
    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.
    Time Frame
    Changes from Baseline to 8th week

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yusra Mahreen Niazi, MS-WHPT*
    Phone
    0334-1075155
    Email
    Yusraniazi57@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huma Riaz, PHD*
    Organizational Affiliation
    Riphah International University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23569140
    Citation
    Bi X, Zhao J, Zhao L, Liu Z, Zhang J, Sun D, Song L, Xia Y. Pelvic floor muscle exercise for chronic low back pain. J Int Med Res. 2013 Feb;41(1):146-52. doi: 10.1177/0300060513475383. Epub 2013 Jan 23.
    Results Reference
    background
    PubMed Identifier
    25006337
    Citation
    Pedraza R, Nieto J, Ibarra S, Haas EM. Pelvic muscle rehabilitation: a standardized protocol for pelvic floor dysfunction. Adv Urol. 2014;2014:487436. doi: 10.1155/2014/487436. Epub 2014 Jun 11.
    Results Reference
    background
    PubMed Identifier
    31717291
    Citation
    Garcia-Sanchez E, Avila-Gandia V, Lopez-Roman J, Martinez-Rodriguez A, Rubio-Arias JA. What Pelvic Floor Muscle Training Load is Optimal in Minimizing Urine Loss in Women with Stress Urinary Incontinence? A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 8;16(22):4358. doi: 10.3390/ijerph16224358.
    Results Reference
    background
    PubMed Identifier
    33218562
    Citation
    Jacomo RH, Nascimento TR, Lucena da Siva M, Salata MC, Alves AT, da Cruz PRC, Batista de Sousa J. Exercise regimens other than pelvic floor muscle training cannot increase pelvic muscle strength-a systematic review. J Bodyw Mov Ther. 2020 Oct;24(4):568-574. doi: 10.1016/j.jbmt.2020.08.005. Epub 2020 Sep 10.
    Results Reference
    background
    PubMed Identifier
    32302393
    Citation
    Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
    Results Reference
    background
    PubMed Identifier
    35315777
    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.
    Results Reference
    background
    PubMed Identifier
    35090464
    Citation
    Widdison R, Rashidi A, Whitehead L. Effectiveness of mobile apps to improve urinary incontinence: a systematic review of randomised controlled trials. BMC Nurs. 2022 Jan 28;21(1):32. doi: 10.1186/s12912-022-00812-6.
    Results Reference
    background
    PubMed Identifier
    35385519
    Citation
    Gron Jensen LC, Boie S, Axelsen S. International consultation on incontinence questionnaire - Urinary incontinence short form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employees. PLoS One. 2022 Apr 6;17(4):e0266479. doi: 10.1371/journal.pone.0266479. eCollection 2022.
    Results Reference
    background

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    Development and Validation of Pelvi-Fit App

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