Mixed Urinary IncontinenceARDT-MUINCT07689409
Bladder Training Supported by Alarm Reminders and Distraction Techniques for Mixed Urinary Incontinence
A study testing Bladder Training Supported by Alarm Reminders and Distraction Techniques and Routine Outpatient Care in people with Mixed Urinary Incontinence and Urinary Incontinence, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effectiveness of bladder training supported by smartphone alarm reminders and distraction techniques in women with persistent mixed urinary incontinence who continued to experience symptoms despite completing pelvic floor muscle exercise (PFME) therapy at least six months… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mixed Urinary Incontinence, Urinary Incontinence
- What is being tested?
- Bladder Training Supported by Alarm Reminders and Distraction Techniques and Routine Outpatient Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-65 years.
- Physician-diagnosed mixed urinary incontinence.
- Previously received pelvic floor muscle exercise (PFME) as the sole treatment for urinary incontinence.
- Completed PFME therapy at least six months before enrollment.
- Continued to experience urinary incontinence symptoms after completion of PFME therapy.
- Owned and were able to use a smartphone.
- Were not receiving any active treatment for urinary incontinence during the study period.
- Provided written informed consent.
Who cannot join
- Urinary tract infection.
- Neurological disorders affecting bladder function.
- Pregnancy.
- Active treatment for urinary incontinence.
- Previous bladder training.
- Previous biofeedback therapy.
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- Previous magnetic chair therapy.
- Cognitive impairment.
- Any medical condition that could interfere with participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35620
About this study
Official title: Effectiveness of Bladder Training Supported by Alarm Reminders and Distraction Techniques in Women With Persistent Mixed Urinary Incontinence Following Pelvic Floor Muscle Exercise Therapy: A Randomized Controlled Trial
This randomized controlled trial evaluated the effectiveness of bladder training supported by smartphone alarm reminders and distraction techniques in women with persistent mixed urinary incontinence who continued to experience symptoms despite completing pelvic floor muscle exercise (PFME) therapy at least six months previously. Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to either an intervention group or a control group. The intervention group received an 8-week bladder training program supported by alarm reminders and distraction techniques, while the control group received routine care. Outcomes included urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence to bladder training.
Read the detailed description
Mixed urinary incontinence is a common condition that negatively affects women's physical, psychological, and social well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment, many women continue to experience urinary incontinence despite completing therapy. Effective management strategies for women with persistent symptoms after PFME remain limited.
The purpose of this randomized controlled trial was to evaluate whether bladder training supported by smartphone alarm reminders and distraction techniques improves urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence in women with persistent mixed urinary incontinence following completed PFME therapy.
Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to an intervention group or a control group. The intervention group received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques, whereas the control group received routine outpatient care. Clinical outcomes were assessed using validated questionnaires, bladder diaries, and the standardized one-hour Pad Test.
- Conditions
- Mixed Urinary Incontinence, Urinary Incontinence
- Being tested
- Bladder Training Supported by Alarm Reminders and Distraction Techniques, Routine Outpatient Care
- Keywords
- Mixed Urinary Incontinence, Bladder Training, Pelvic Floor Muscle Exercise, Alarm Reminder, Distraction Technique
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder Training Supported by Alarm Reminders and Distraction TechniquesBehavioural
Participants received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques. The intervention included pelvic floor muscle contractions, urgency suppression strategies, timed voiding with gradually increasing voiding intervals, smartphone alarm reminders, and bead-counting distraction techniques.
Routine Outpatient CareOther
Participants received routine outpatient follow-up care without structured bladder training during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Training Supported by Alarm Reminders and Distraction Techniques | Experimental | Participants received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques. The intervention included pelvic floor muscle contractions, urgency suppression strategies, timed voiding with gradually increasing voiding intervals, smartphone alarm reminders, and bead-counting distraction techniques. Receives: Behavioral: Bladder Training Supported by Alarm Reminders and Distraction Techniques |
| Routine Outpatient Care | Active comparator | Participants received routine outpatient follow-up care without structured bladder training during the study period. After completion of data collection, educational materials and distraction objects were provided. Receives: Other: Routine Outpatient Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence Severity
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.
Measured: Baseline and Week 8
Secondary outcomes (1)
Objective Urine Loss
Objective urine loss was measured using the standardized one-hour Pad Test.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start15 Jun 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Urinary IncontinenceStudies 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
- Model description
- Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before being randomly assigned to either the intervention or control group.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan ÇETİN, Izmir Katip Celebi University
- Investigators
- Perihan Çetin, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689409
- Sponsor's protocol ID
- 2022-GOKAE-0250
- Acronym
- ARDT-MUI
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent obtained from participants did not include permission for public data sharing. De-identified data may be made available from the corresponding author upon reasonable request and subject to institutional ethics approval and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bladder Training Supported by Alarm Reminders and Distraction Techniques in Women With Persistent Mixed Urinary Incontinence Following Pelvic Floor Muscle Exercise Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07689409
- Acronym / sponsor ID
- ARDT-MUI / 2022-GOKAE-0250
- Conditions
- Mixed Urinary Incontinence, Urinary Incontinence
- Keywords
- Mixed Urinary Incontinence, Bladder Training, Pelvic Floor Muscle Exercise, Alarm Reminder, Distraction Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 8 Jul 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.
This randomized controlled trial evaluated the effectiveness of bladder training supported by smartphone alarm reminders and distraction techniques in women with persistent mixed urinary incontinence who continued to experience symptoms despite completing pelvic floor muscle exercise (PFME) therapy at least six months previously. Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to either an intervention group or a control group. The intervention group received an 8-week bladder training program supported by alarm reminders and distraction techniques, while the control group received routine care. Outcomes included urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence to bladder training.
Detailed description
Mixed urinary incontinence is a common condition that negatively affects women's physical, psychological, and social well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment, many women continue to experience urinary incontinence despite completing therapy. Effective management strategies for women with persistent symptoms after PFME remain limited.
The purpose of this randomized controlled trial was to evaluate whether bladder training supported by smartphone alarm reminders and distraction techniques improves urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence in women with persistent mixed urinary incontinence following completed PFME therapy.
Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to an intervention group or a control group. The intervention group received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques, whereas the control group received routine outpatient care. Clinical outcomes were assessed using validated questionnaires, bladder diaries, and the standardized one-hour Pad Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before being randomly assigned to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Bladder Training Supported by Alarm Reminders and Distraction Techniques | Experimental | Behavioral: Bladder Training Supported by Alarm Reminders and Distraction TechniquesParticipants received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques. The intervention included pelvic floor muscle contractions, urgency suppression strategies, timed voiding with gradually increasing voiding intervals, smartphone alarm reminders, and bead-counting distraction techniques. |
| Routine Outpatient Care | Active comparator | Other: Routine Outpatient CareParticipants received routine outpatient follow-up care without structured bladder training during the study period. After completion of data collection, educational materials and distraction objects were provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 18-65 years.
- Physician-diagnosed mixed urinary incontinence.
- Previously received pelvic floor muscle exercise (PFME) as the sole treatment for urinary incontinence.
- Completed PFME therapy at least six months before enrollment.
- Continued to experience urinary incontinence symptoms after completion of PFME therapy.
Key exclusion criteria (9 listed)
- Urinary tract infection.
- Neurological disorders affecting bladder function.
- Pregnancy.
- Active treatment for urinary incontinence.
- Previous bladder training.
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 |
|---|---|---|
| Bladder Training Supported by Alarm Reminders and Distraction TechniquesParticipants received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques. The intervention included pelvic floor muscle contractions, urgency suppression strategies, timed voiding with gradually increasing voiding intervals, smartphone alarm reminders, and bead-counting distraction techniques. | Behavioural | Bladder Training Supported by Alarm Reminders and Distraction Techniques |
| Routine Outpatient CareParticipants received routine outpatient follow-up care without structured bladder training during the study period. | Other | Routine Outpatient Care |
Primary outcome
Urinary Incontinence Severity
Time frame: Baseline and Week 8
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.
1 secondary outcome
Objective Urine Loss
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent obtained from participants did not include permission for public data sharing. De-identified data may be made available from the corresponding author upon reasonable request and subject to institutional ethics approval and applicable regulations.
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Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital
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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.
Perihan Çetin principal investigator
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Training Supported by Alarm Reminders and Distraction Techniques and Routine Outpatient Care in people with Mixed Urinary Incontinence and Urinary Incontinence, run by Izmir Katip Celebi University 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary Incontinence Severity (time frame: Baseline and Week 8). 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 10 Jul 2026.