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Completed

NCT Number: NCT07689409

Bladder Training Supported by Alarm Reminders and Distraction Techniques for Mixed Urinary Incontinence

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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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Routine Outpatient Care

Other

Participants received routine outpatient follow-up care without structured bladder training during the study period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective Urine Loss

    Time frame: Baseline and Week 8

    Objective urine loss was measured using the standardized one-hour Pad Test.

Other outcomes

  1. Urinary Symptom Distress

    Time frame: Baseline and Week 8

    Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study 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

Acronym: ARDT-MUI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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