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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder Training Supported by Alarm Reminders and Distraction Techniques | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Incontinence Severity | Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Urine Loss | Objective urine loss was measured using the standardized one-hour Pad Test. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Symptom Distress | Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6). | Baseline and Week 8 |
Inclusion Criteria:
Women aged 18-65 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perihan Çetin | Izmir Katip Celebi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Katip Celebi University Ataturk Training and Research Hospital | Izmir | İzmir | 35620 | Turkey (Türkiye) |
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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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.
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This was an open-label trial because participants and investigators were aware of group allocation.
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|
| Routine Outpatient Care | Other | Participants received routine outpatient follow-up care without structured bladder training during the study period. |
|
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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