Development and Validation of Pelvi-Fit App

NCT05909969 | Completed

• 1 other identifier: RiphahIU Yusra Niazi
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  Changes from Baseline to 8th week

• 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.

  Changes from Baseline to 8th week

Study Arms (2)

Pelvi-Fit Group

EXPERIMENTAL

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

Other: Pelvi-Fit app Training

Control

OTHER

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

Other: Control

Interventions

Pelvi-Fit app Training OTHER

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

Pelvi-Fit Group

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients of neurological conditions; SCI, Stroke.
• Not friendly to use mobile apps.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Al-Hussain Miternity Clinic

Mianwali, Punjab Province, 42206, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 23569140 BACKGROUND

• 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.

  PMID: 25006337 BACKGROUND

• 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.

  PMID: 31717291 BACKGROUND

• 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.

  PMID: 33218562 BACKGROUND

• 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.

  PMID: 32302393 BACKGROUND

• 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.

  PMID: 35315777 BACKGROUND

• 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.

  PMID: 35090464 BACKGROUND

• 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.

  PMID: 35385519 BACKGROUND

• Niazi YM, Riaz H, Naeem M, Saeed A. Development of the Pelvi-Fit app for women with urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2025 Dec;315:114726. doi: 10.1016/j.ejogrb.2025.114726. Epub 2025 Sep 17.

  PMID: 40997686 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Huma Riaz, PHD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a Pretest-Postest Design with parallel assignment of patients into two groups.

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 18, 2023
• Study Start: July 12, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)