MenopauseUI Sleep QoLNCT07395557
Effect of a Pender Model-Based Mobile App on Symptom Severity, Quality of Life, and Sleep in Menopausal Women With Urinary Incontinence
A study testing Education and counseling delivered via a mobile application based on Pender's Health Promotion Model in people with Menopause and Urinary Incontinence, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause, Urinary Incontinence, Mobile Applications
- What is being tested?
- Education and counseling delivered via a mobile application based on Pender's Health Promotion Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Ownership of an Android or iOS smartphone with internet access
- Willingness to participate in the study
- No diagnosed psychiatric disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: 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
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.
Read more
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.
Read the 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
- Being tested
- Education and counseling delivered via a mobile application based on Pender's Health Promotion Model
- Keywords
- Menopause, Urinary Incontinence, Mobile Applications, Quality of Life, Sleep, Pender's Health Promotion Model
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and counseling delivered via a mobile application based on Pender's Health Promotion ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Doğancı, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395557
- Sponsor's protocol ID
- 200902038
- Acronym
- UI Sleep QoL
- Status last verified
- Aug 2025
- First submitted
- 15 Sep 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07395557
- Acronym / sponsor ID
- UI Sleep QoL / 200902038
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with urinary incontinence receiving mobile-based exercise interventions | Experimental | Behavioral: Education and counseling delivered via a mobile application based on Pender's Health Promotion ModelBeing 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 |
| Individuals receiving routine care | No intervention | –Individuals will receive routine care, and no intervention will be applied. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and counseling delivered via a mobile application based on Pender's Health Promotion ModelQuestionnaires 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. | Behavioural | Individuals with urinary incontinence receiving mobile-based exercise interventions |
Primary outcome
Introductory Information Form
Time frame: 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)
Time frame: 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 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.
Incontinence Severity Index (ISI)
Time frame: 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 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.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: 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 0.97 for questions 3, 4, and 5, respectively.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and counseling delivered via a mobile application based on Pender's Health Promotion Model in people with Menopause and Urinary Incontinence, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.