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NCT07395557: UI Sleep QoL
Effect of a Pender Model-Based Mobile App on Symptom Severity, Quality of Life, and Sleep in Menopausal Women With Urinary Incontinence
NA trial testing Education and counseling delivered via a mobile application based on Pender's Health Promotion Model in Menopause in 82 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2026
Quick facts
| Lead sponsor | Saglik Bilimleri Universitesi |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 1 August 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Education and counseling delivered via a mobile application based on Pender's Health Promotion Model
Conditions studied
- Menopause — all drugs for Menopause →
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Mobile Applications — all drugs for Mobile Applications →
- Quality of Life — all drugs for Quality of Life →
Sponsor
Saglik Bilimleri Universitesi — full company profile →
Who can join
Adults 40 to 65, female only, with Menopause or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07395557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07395557 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saglik Bilimleri Universitesi
- Last refreshed: 9 February 2026
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