NCT07395557

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

The Effects of Education and Counseling Applied Via Mobile Application Based on the Pender Health Promotion Model on Symptom Severity, Quality of Life and Sleep Quality in Women With Urinary Incontinence During Menopause

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Menopause is a natural process marking the end of the reproductive period and is accompanied by hormonal changes. These changes can significantly affect women's physical, emotional, mental, and social well-being. Symptoms experienced during and after the menopausal transition vary among individuals, and the severity of these symptoms may influence daily life activities. A woman's awareness of menopause and recognition of its symptoms play an important role in determining quality of life. During menopause, the vascular and vasomotor systems, skeletal structure, and genitourinary system are commonly affected. Frequently reported symptoms include urinary incontinence, hot flashes, night sweats, vaginal problems, sleep disturbances, anxiety, irritability, and other physical and emotional changes. Genitourinary symptoms associated with hormonal changes may negatively affect women's quality of life and self-care abilities. Urinary incontinence is a health problem that arises from dysfunction of the continence mechanism and has a profound impact on the quality of life of menopausal women. It is associated with various individual and environmental risk factors. Factors such as age, sociodemographic characteristics, reproductive history, chronic conditions, lifestyle factors, and obesity may contribute to the development of urinary incontinence during menopause. As key members of the multidisciplinary healthcare team, nurses play an important role in identifying urinary incontinence, teaching and implementing conservative treatment methods, and providing counseling on preventive strategies. Management of urinary incontinence includes pharmacological and non-pharmacological treatments, behavioral approaches, and surgical interventions. The Health Promotion Model focuses on understanding health-promoting behaviors and evaluating factors that influence these behaviors. The model emphasizes that health behaviors are shaped by individuals' past experiences and perceptions, and that thoughts guide actions. Its main concepts include the individual, environment, care, health, and illness. Approaches based on health promotion models may strengthen women's ability to cope with symptoms related to urinary incontinence. In addition, the integration of internet-based tools and mobile applications into healthcare services plays an important role in supporting disease prevention, early detection, care, and treatment processes. These approaches facilitate access to healthcare services and enhance communication with healthcare professionals. This study aims to evaluate the effects of education and counseling delivered through a mobile application based on a health promotion model on symptom severity, quality of life, and sleep quality in menopausal women with urinary incontinence.

Conditions

• Menopause
• Urinary Incontinence
• Mobile Applications
• Quality of Life
• Sleep

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Turkey (Türkiye)