Urinary IncontinenceUI ProgramNCT07324668
Effects of Multiple Intervention on Postmenopausal Women With UI
A study testing Combined Exercise Program in people with Urinary Incontinence and Postmenopausal, run by Ondokuz Mayıs University.
Trial summary
Study The purpose of this clinical trial was to investigate the effects of a multi-intervention approach, including Kegel and Tai Chi exercises, on quality of life, self-efficacy, and urinary incontinence severity in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Urinary Incontinence, Postmenopausal
- What is being tested?
- Combined Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Feb 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being female
- Having undergone menopause
- Willingness to participate in the study
- No communication barriers
- Not receiving any treatment for urinary incontinence
- Owning a smartphone
- Having WhatsApp installed
- Experiencing urinary leakage when coughing or sneezing, according to the International Continence Society (ICS) definition
Who cannot join
- Having communication barriers
- Not being in menopause
- Not owning a smartphone
- Not experiencing urinary incontinence
- Having received any treatment for urinary incontinence
- Having undergone surgical menopause
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of a Multiple Intervention Approach Applied to Postmenopausal Women on Quality of Life, Self-efficacy, and Urinary Incontinence Severity: a Temporal Analysis
Study
The purpose of this clinical trial was to investigate the effects of a multi-intervention approach, including Kegel and Tai Chi exercises, on quality of life, self-efficacy, and urinary incontinence severity in postmenopausal women.
Read more
Key Questions the Study Aims to Answer:
How does the multi-intervention approach affect quality of life?
Does the multi-intervention approach affect women's self-efficacy?
How does the multi-intervention approach affect urinary incontinence severity?
How does the frequency of exercises (3 days per week vs. 6 days per week) affect these outcomes?
Do the effects of the intervention change temporally over the 8-week period?
Who is Eligible?
Women aged 45 and over who have gone through menopause
Those who wish to volunteer for the study
Those who have no communication barriers
Those who have not previously received treatment for urinary incontinence
Those who can use a smartphone or WhatsApp
Those who experience urine leakage when coughing or sneezing
Study Application:
The exercises will be administered for 8 weeks.
Participants will be taught how to perform the exercises and will be demonstrated through brochures and videos.
Reminders will be provided during the exercises.
- Conditions
- Urinary Incontinence, Postmenopausal
- Being tested
- Combined Exercise Program
- Keywords
- Postmenopause, Women's health, Multimodal intervention, Urinary incontinence, Quality of life, Effectiveness
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise ProgramBehavioural
Participants will receive education on urinary incontinence, Kegel and Tai Chi exercises, brochures and videos, and perform exercises 3 days/week for 8 weeks with reminders
Combined Exercise ProgramBehavioural
Participants will receive same education and materials as Group 1 and perform exercises 6 days/week for 8 weeks with reminders.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 (Tai Chi and Kegel, 3 days/week) | Experimental | articipants will perform Tai Chi and Kegel exercises 3 days per week for 8 weeks. Receives: Behavioral: Combined Exercise Program |
| Intervention Group 2 (Tai Chi and Kegel, 6 days/week) | Experimental | Participants will perform Tai Chi and Kegel exercises 6 days per week for 8 weeks. Receives: Behavioral: Combined Exercise Program |
| Control Group | No intervention | Participants will receive no exercise or educational intervention and will continue their usual daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]
Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.
Measured: 8 weeks (baseline and post-intervention)
Secondary outcomes (2)
Quality of Life Related to Urinary Incontinence
Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.
Measured: 8 weeks (baseline and post-intervention)
Self-Efficacy in Managing Urinary Incontinence
Participants' self-efficacy will be measured using a validated scale, comparing baseline and post-test scores.
Measured: Baseline and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: 1. Experimental Group 1 will perform Tai Chi and Kegel exercises 3 days per week, 2. Experimental Group 2 will perform Tai Chi and Kegel exercises 6 days per week, and 3. the Control Group will receive no intervention. All groups will be evaluated at baseline and after 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma SOYANIT ERASLAN, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324668
- Sponsor's protocol ID
- 2025-1075
- Acronym
- UI Program
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multiple Intervention Approach Applied to Postmenopausal Women on Quality of Life, Self-efficacy, and Urinary Incontinence Severity: a Temporal Analysis
- ClinicalTrials.gov ID
- NCT07324668
- Acronym / sponsor ID
- UI Program / 2025-1075
- Conditions
- Urinary Incontinence, Postmenopausal
- Keywords
- Postmenopause, Women's health, Multimodal intervention, Urinary incontinence, Quality of life, Effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 7 Jan 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.
Study
The purpose of this clinical trial was to investigate the effects of a multi-intervention approach, including Kegel and Tai Chi exercises, on quality of life, self-efficacy, and urinary incontinence severity in postmenopausal women.
Key Questions the Study Aims to Answer:
How does the multi-intervention approach affect quality of life?
Does the multi-intervention approach affect women's self-efficacy?
How does the multi-intervention approach affect urinary incontinence severity?
How does the frequency of exercises (3 days per week vs. 6 days per week) affect these outcomes?
Do the effects of the intervention change temporally over the 8-week period?
Who is Eligible?
Women aged 45 and over who have gone through menopause
Those who wish to volunteer for the study
Those who have no communication barriers
Those who have not previously received treatment for urinary incontinence
Those who can use a smartphone or WhatsApp
Those who experience urine leakage when coughing or sneezing
Study Application:
The exercises will be administered for 8 weeks.
Participants will be taught how to perform the exercises and will be demonstrated through brochures and videos.
Reminders will be provided during the exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: 1. Experimental Group 1 will perform Tai Chi and Kegel exercises 3 days per week, 2. Experimental Group 2 will perform Tai Chi and Kegel exercises 6 days per week, and 3. the Control Group will receive no intervention. All groups will be evaluated at baseline and after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 (Tai Chi and Kegel, 3 days/week) | Experimental | Behavioral: Combined Exercise Programarticipants will perform Tai Chi and Kegel exercises 3 days per week for 8 weeks. |
| Intervention Group 2 (Tai Chi and Kegel, 6 days/week) | Experimental | Behavioral: Combined Exercise ProgramParticipants will perform Tai Chi and Kegel exercises 6 days per week for 8 weeks. |
| Control Group | No intervention | –Participants will receive no exercise or educational intervention and will continue their usual daily routines. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Being female
- Having undergone menopause
- Willingness to participate in the study
- No communication barriers
- Not receiving any treatment for urinary incontinence
Key exclusion criteria (7 listed)
- Having communication barriers
- Not being in menopause
- Not owning a smartphone
- Not experiencing urinary incontinence
- Having received any treatment for urinary incontinence
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 |
|---|---|---|
| Combined Exercise ProgramParticipants will receive education on urinary incontinence, Kegel and Tai Chi exercises, brochures and videos, and perform exercises 3 days/week for 8 weeks with reminders | Behavioural | Intervention Group 1 (Tai Chi and Kegel, 3 days/week) |
| Combined Exercise ProgramParticipants will receive same education and materials as Group 1 and perform exercises 6 days/week for 8 weeks with reminders. | Behavioural | Intervention Group 2 (Tai Chi and Kegel, 6 days/week) |
Primary outcome
Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi]
Time frame: 8 weeks (baseline and post-intervention)
Quality of life related to urinary incontinence will be assessed using a validated questionnaire. Differences from baseline to post-test will be evaluated.
2 secondary outcomes
Quality of Life Related to Urinary Incontinence
Time frame: 8 weeks (baseline and post-intervention)
Self-Efficacy in Managing Urinary Incontinence
Time frame: Baseline and 8 weeks post-intervention
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 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise Program in people with Urinary Incontinence and Postmenopausal, run by Ondokuz Mayıs University.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ŞEYMA SOYANIT ERASLAN (+90 368 271 57 57 / 6571, seymasoyanitt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Incontinence Severity Measured by [İnkontinans Şiddet İndeksi] (time frame: 8 weeks (baseline and post-intervention)). 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 7 Jan 2026.