Effect of Mobile Application on Urinary Incontinence

NCT05404386 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-01-09

No results posted yet for this study

Summary

The first phase was designed in a methodological pattern in order to develop, usability, and performance of mobile application (mobileapp) called "My Fight with Incontinence". Aim of the second phase of the study was to evaluate the effect of mobileapp developed according to the health belief model on incontinence symptoms, Kegel exercise compliance, health belief and quality of life towards UI and kegel exercises in women with UI. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 3-month follow-up period. The research will be carried out in the Urology service and polyclinics of Eskişehir Osmangazi University Health Practice and Research Hospital. The study population of the research consists of 203 female patients over the age of 18 who were followed up with the diagnosis of Stress, Urge, and Mixed Type UI. Sample selection will not be made in the first stage of the study, and mobileapp will be tested on people aged 18 and over who can be reached, working, studying, or receiving treatment at Eskişehir Osmangazi University Training, Application and Research Hospital and Eskişehir Osmangazi University. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 96 individuals, 48 in each group, with an increase of 20%, will form the research group. In the second stage of the study, "Incontinence Severity Index Questionnaire", "International Urinary Incontinence Inquiry Form-Short Form (ICIQ-SF)", "Kegel Exercise Compliance Follow-up Form", "Health Belief Scale for Urinary Incontinence and Kegel Exercise", "Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7)" will be used. Control group will be given a training booklet called "My Fight with Incontinence", which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to UI after the pre-tests are applied. After pre-tests are applied to the study group, "My Fight with Incontinence" mobileapp will be installed on their mobile phones by researcher. Reminders will be sent to the patients on a regular basis via the mobileapp. Participants in both the control and study groups will be provided with the link of the survey form created via google forms in the 6th and 12th weeks by sending an SMS.

Conditions

  • Urinary Incontinence,Stress
  • Urinary Incontinence, Urge
  • Urinary Incontinence, Mixed
  • Symptoms
  • Kegel Exercises
  • Health, Subjective
  • Quality of Life

Interventions

OTHER

Training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence.

After the participants enrolled in the study, a training booklet prepared by the researchers on healthy lifestyle behaviors, bladder training, and Kegel exercises related to urinary incontinence will be given to the participants.

OTHER

3 months follow-up

Follow-ups will be made 3 times in total, on the basis of pre-test (baseline), intermediate follow-up test (6th week), and post-test (12th week).

BEHAVIORAL

Mobile application which named as "My Fighting with Incontinence"

The mobile application "My Fighting with Incontinence" aims to reduce incontinence symptoms of women with UI, ensure compliance with Kegel exercises, increase health belief and quality of life regarding UI and kegel exercises, and also allow researchers to be included in the awareness and management process.

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Principal Investigators

  • Pınar Duru, PhD · Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-02-01
Completion
2024-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404386 on ClinicalTrials.gov