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

NCT07689409 | Completed

• 1 other identifier: 2022-GOKAE-0250
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence; Mixed Urinary Incontinence

Keywords

Mixed Urinary Incontinence; Bladder Training; Pelvic Floor Muscle Exercise; Alarm Reminder; Distraction Technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective Urine Loss

  Baseline and Week 8

Other Outcomes (1)

• Urinary Symptom Distress

  Baseline and Week 8

Study Arms (2)

Bladder Training Supported by Alarm Reminders and Distraction Techniques

EXPERIMENTAL

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

Routine Outpatient Care

ACTIVE COMPARATOR

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

Interventions

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.

Bladder Training Supported by Alarm Reminders and Distraction Techniques

Routine Outpatient Care OTHER

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

Routine Outpatient Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Perihan Çetin

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label trial because participants and investigators were aware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before being randomly assigned to either the intervention or control group.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: June 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)