What this trial studies
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.
Conditions in scope
- Menopause
- Urinary Incontinence
- Mobile Applications
- Quality of Life
- Sleep
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…
Who can join
Women only · Ages 40 Years to 65 Years
Inclusion criteria
- 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
Exclusion criteria
- 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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Istanbul | Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital | Unknown |
Status & timeline
- Overall status: Active, not recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-08-01
- Primary completion: 2026-06-01
- Last update posted: 2026-02-09
- First posted: 2026-02-09
Sponsor & contact
Lead sponsor: Saglik Bilimleri Universitesi (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Introductory Information Form (up to 24 weeks)
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. - Urinary Incontinence Quality of Life Scale (I-QOL) (up to 24 weeks)
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… - Incontinence Severity Index (ISI) (up to 24 weeks)
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… - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) (up to 24 weeks)
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… - Pittsburgh Sleep Quality Index (PSQI) (up to 24 weeks)
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…
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07395557 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.