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Bladder Training Supported by Alarm Reminders and Distraction Techniques for Mixed Urinary Incontinence (ARDT-MUI)

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

111

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • İzmir
      • Izmir, İzmir, Tyrkiet (Türkiye), 35620
        • Izmir Katip Celebi University Ataturk Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Andet: Routine Outpatient Care
Participants received routine outpatient follow-up care without structured bladder training during the study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary Incontinence Severity
Tidsramme: Baseline and Week 8
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.
Baseline and Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Urine Loss
Tidsramme: Baseline and Week 8
Objective urine loss was measured using the standardized one-hour Pad Test.
Baseline and Week 8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary Symptom Distress
Tidsramme: Baseline and Week 8
Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).
Baseline and Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Izmir Katip Celebi University

Efterforskere

  • Ledende efterforsker: Perihan Çetin, Izmir Katip Celebi University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2022

Primær færdiggørelse (Faktiske)

15. december 2022

Studieafslutning (Faktiske)

15. december 2022

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2022-GOKAE-0250

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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