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

NCT07395557 | Active Not Recruiting DMC

• 1 other identifier: 200902038
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Menopause; Urinary Incontinence; Mobile Applications; Quality of Life; Sleep; Pender's Health Promotion Model

Outcome Measures

Primary Outcomes (5)

• Introductory Information Form

  The research data will be collected using a form developed by the researcher based on the literature, which includes participants' sociodemographic, obstetric, and gynecological information.

  up to 24 weeks

• Urinary Incontinence Quality of Life Scale (I-QOL)

  Developed by Wagner and Hu in 1998 to assess the quality of life of patients with urinary incontinence, the scale consists of 22 items and three subdimensions. Its validity and reliability in Turkish were established by Özer Doğan and colleagues. The subdimensions are: restriction of behaviors (items 1,2,3,4,10,11,13,20), psychosocial impact (items 5,6,7,9,15,16,17,21,22), and social isolation (items 8,12,14,18,19). All items are rated on a five-point Likert scale (1=very much, 2=quite a lot, 3=moderate, 4=a little, 5=none). The I-QOL and subscale scores are calculated by summing item scores and dividing by the number of items. To facilitate interpretation, the total score is converted to a scale from 0 (lowest quality of life) to 100 (highest quality of life). Higher scores indicate better quality of life.

  up to 24 weeks

• Incontinence Severity Index (ISI)

  Developed by Sandvik et al. in 1993 in Norway to evaluate the severity of urinary incontinence in women. The Turkish validity and reliability study was conducted by Hazar and Şirin in 2008. This simple, short, valid, and reliable scale is frequently recommended (level A) for severity assessment. The ISI consists of two questions, and the total score is obtained by multiplying the frequency of urine leakage by the amount leaked, ranging from 1 to 12. According to ISI scores, 1-2 points indicate mild; 3-6 moderate; 8-9 severe; and 12 very severe urinary incontinence. Mild incontinence typically refers to occasional drops of urine a few times a month, moderate to daily drops, and severe to at least once a week of large amounts of leakage. The Turkish validity and reliability study reported a Cronbach alpha of 0.67.

  up to 24 weeks

• International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

  Developed by Avery et al. in 2004 to assess the prevalence, frequency, perceived cause, and impact of urinary incontinence on quality of life. The ICIQ consists of an unscored self-diagnostic item and three scored items. The Turkish validity and reliability study was conducted by Çetinel et al. in 2004. Cronbach's alpha was 0.71, with stability results of 0.98, 0.95, and 0.97 for questions 3, 4, and 5, respectively.

  up to 24 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Developed by Buysse et al. in 1989, with Turkish validity and reliability conducted by Ağargün et al. in 1996, reporting a Cronbach alpha of 0.79. PSQI is a self-report scale evaluating sleep quality and disturbances over the past month. The scale consists of 24 items in seven components: subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbances (component 5), use of sleep medication (component 6), and daytime dysfunction (component 7). The first 19 items are self-reported, while the last five are answered by a roommate or partner. Items are scored 0-3, with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality and greater disturbances. A total score above 5 indicates clinically poor sleep quality.

  up to 24 weeks

Study Arms (2)

Individuals with urinary incontinence receiving mobile-based exercise interventions

EXPERIMENTAL

Being a woman aged between 40 and 65 Being postmenopausal Experiencing urinary incontinence Being literate Having sufficient proficiency in understanding and speaking Turkish Having no diagnosed psychiatric disorders Owning a smartphone with Android or iOS operating system and having internet access Volunteering to participate in the study

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

Individuals receiving routine care

NO INTERVENTION

Individuals will receive routine care, and no intervention will be applied.

Interventions

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

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.

Individuals with urinary incontinence receiving mobile-based exercise interventions

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Menopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient admission to the Urology Clinic at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
• Female, aged 40-65 years
• Currently in menopause
• Experiencing urinary incontinence
• Literate (able to read and write)
• Adequate comprehension and expression skills in Turkish
• Ownership of an Android or iOS smartphone with internet access
• Willingness to participate in the study
• No diagnosed psychiatric disorders

You may not qualify if:

• Withdrawal from the study by the participant
• Not actively using the mobile application during the study period
• Failure to complete required forms while using the mobile application

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Educational Status

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: February 9, 2026
• Study Start: August 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)