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临床试验/NCT07689409
NCT07689409已完成不适用

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

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
1
主要终点
Urinary Incontinence Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

This was an open-label trial because participants and investigators were aware of group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Urinary Incontinence Severity

时间窗: Baseline and Week 8

Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.

次要结局

  • Objective Urine Loss(Baseline and Week 8)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Perihan ÇETİN

Assistant Professor

Izmir Katip Celebi University

研究点 (1)

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