Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35620, Turkey (Türkiye)
NCT Number: NCT07689409
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.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Izmir, İzmir, 35620, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women aged 18-65 years.
Exclusion criteria
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.
Participants received routine outpatient follow-up care without structured bladder training during the study period.
Time frame: Baseline and Week 8
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.
Time frame: Baseline and Week 8
Objective urine loss was measured using the standardized one-hour Pad Test.
Time frame: Baseline and Week 8
Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).
Izmir Katip Celebi University
Other
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
Acronym: ARDT-MUI
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