NCT05347472

Brief Summary

Therapeutic exercise has been shown to be effective in Urinary Incontinence management. However, there is a lack of physiotherapy services provided such necessary treatment. Moreover, mobile applications are becoming popular, and there are limited applications designed to help women with Urinary Incontinence. Consequently, no study investigated the effect of a smartphone application with specific exercises program for Urinary Incontinence management. Therefore, the aim of this study is to determine the effect of a Urinary Incontinence exercises delivered by smartphone application on UI outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

29 days

First QC Date

April 21, 2022

Last Update Submit

January 21, 2025

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

  • International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol).

    The questionnaire assesses the quality of life of women with UI.

    Change from baseline to 4 weeks and 16 weeks

  • Arabic International Consultation on Incontinence Questionnaire-Urinary

    Provides measurement of severity of UI and its impact on daily life

    Change from baseline to 4 weeks and 16 weeks

  • Arabic version of Multidimensional Scale of Perceived Social

    Self-report measure of subjectively assessed social support

    Change from baseline to 4 weeks and 16 weeks

Secondary Outcomes (2)

  • Short Form Health Survey

    Change from baseline to 4 weeks and 16 weeks

  • Depression Anxiety Stress Scales

    Change from baseline to 4 weeks and 16 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

In this group, women will receive the smartphone application intervention that will include daily physical therapy exercises program

Other: Smartphone application

Control group

PLACEBO COMPARATOR

In this group, women will receive the sham application that includes information and general advice about UI only

Other: Sham Smartphone application

Interventions

Smartphone applicationOTHER

the smartphone application intervention will consist daily physical therapy exercises program. The application will include all the videos about the exercises and all information about the repetition, frequency, intensity, and position.

Experimental group
Sham Smartphone applicationOTHER

ham application that includes information and general advice about UI only

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women with UI
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients diagnosed with UI, aged between 18-40, ability to read and own and use smartphone applications

You may not qualify if:

  • Women with no medical diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah University Hospital

Irbid, Irbid Governorate, 22110, Jordan

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saddam F Kanaan, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

May 1, 2023

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)