Bladder Training Supported by Alarm Reminders and Distraction Techniques for Mixed Urinary Incontinence (ARDT-MUI)
8 juli 2026 bijgewerkt door: Perihan ÇETİN, Izmir Katip Celebi University
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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
111
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
İzmir
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Izmir, İzmir, Turkije (Türkiye), 35620
- Izmir Katip Celebi University Ataturk Training and Research Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
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.
Exclusion Criteria:
- Urinary tract infection.
- Neurological disorders affecting bladder function.
- Pregnancy.
- Active treatment for urinary incontinence.
- Previous bladder training.
- Previous biofeedback therapy.
- Previous magnetic chair therapy.
- Cognitive impairment.
- Any medical condition that could interfere with participation or completion of the study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Bladder Training Supported by Alarm Reminders and Distraction Techniques
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.
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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.
|
|
Actieve vergelijker: Routine Outpatient Care
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.
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Participants received routine outpatient follow-up care without structured bladder training during the study period.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Urinary Incontinence Severity
Tijdsspanne: Baseline and Week 8
|
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI).
Higher scores indicate greater urinary incontinence severity.
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Baseline and Week 8
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Objective Urine Loss
Tijdsspanne: Baseline and Week 8
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Objective urine loss was measured using the standardized one-hour Pad Test.
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Baseline and Week 8
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Urinary Symptom Distress
Tijdsspanne: Baseline and Week 8
|
Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).
|
Baseline and Week 8
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Perihan Çetin, Izmir Katip Celebi University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 juni 2022
Primaire voltooiing (Werkelijk)
15 december 2022
Studie voltooiing (Werkelijk)
15 december 2022
Studieregistratiedata
Eerst ingediend
1 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juli 2026
Eerst geplaatst (Werkelijk)
8 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
8 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Mannelijke urogenitale ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Plasstoornissen
- Lagere urinewegsymptomen
- Urologische manifestaties
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Urine-incontinentie
Andere studie-ID-nummers
- 2022-GOKAE-0250
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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