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
About this trial
This is an interventional treatment trial for 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.
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
NCT ID
NCT05909969
First Posted
June 11, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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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