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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Mixed Urinary Incontinence
• Intervention / Treatment: Behavioral: Bladder Training Supported by Alarm Reminders and Distraction Techniques; Other: Routine Outpatient Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Other: Routine Outpatient Care; Participants received routine outpatient follow-up care without structured bladder training during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Urine Loss	Objective urine loss was measured using the standardized one-hour Pad Test.	Baseline and Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Symptom Distress	Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Principal Investigator: Perihan Çetin, Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mixed Urinary Incontinence; Pelvic Floor Muscle Exercise; Bladder Training; Distraction Technique; Alarm Reminder
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence
• Other Study ID Numbers: 2022-GOKAE-0250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No