Effect of a Pender Model-Based Mobile App on Symptom Severity, Quality of Life, and Sleep in Menopausal Women With Urinary Incontinence

NCT07395557 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-02-09

No results posted yet for this study

Summary

Objective: This randomized controlled trial aims to examine the effects of education and counseling delivered through a mobile application based on the Pender Health Promotion Model on symptom severity, quality of life, and sleep quality in menopausal women with urinary incontinence.

Methods: The study was conducted at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, targeting women who presented to the urology outpatient clinic and met the inclusion criteria. The sample consisted of 82 participants, with 41 women in the intervention group and 41 in the control group. To account for potential dropouts during the mobile intervention, the sample size was increased by 20% above the calculated requirement.

Data collection tools included the Descriptive Information Form, Incontinence Quality of Life Questionnaire (I-QOL), Incontinence Severity Index (ISI), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and Pittsburgh Sleep Quality Index (PSQI).

The intervention group received an 8-week mobile application-based education program developed in line with the Pender Health Promotion Model. Additionally, participants in the intervention group were contacted twice weekly by phone for counseling and support. The control group received no educational intervention but was assessed with pre-test and post-test measurements.

Results: Data were analyzed using descriptive statistics, independent and paired sample t-tests, one-way and repeated measures ANOVA, Pearson correlation analysis, and chi-square tests for group homogeneity. The study aims to determine whether the mobile application-based intervention significantly improves urinary incontinence symptoms, quality of life, and sleep quality compared to the control group.

Conclusion: This study may provide evidence supporting the use of mobile health interventions based on health promotion models like Pender's to enhance the management and overall well-being of menopausal women with urinary incontinence.

Conditions

Interventions

BEHAVIORAL

Education and counseling delivered via a mobile application based on Pender's Health Promotion Model

Questionnaires will be given as a pre-test at the initial meeting. After randomization, the intervention group will have a mobile app installed and create a profile. They will read modules, do daily exercises, and fill follow-up forms. Mini-tests after each module require at least 75% correct to continue; otherwise, the module is reread. The intervention lasts 8 weeks, covering fluid intake, urine tracking, diet, healthy eating, bladder, and Kegel exercises. Studies show exercises reduce urinary incontinence after 6 weeks, so 8 weeks is planned. After intervention, questionnaires will be repeated. The control group gets no intervention but completes questionnaires at start and end. Weekly calls support the intervention group's motivation and symptom monitoring; the control group is called at weeks 3 and 8. After the study, the app is given to controls. Data is used only for research and accessible to researchers and admins.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-06-01
Completion
2026-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

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 NCT07395557 on ClinicalTrials.gov