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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
İzmir
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Izmir、İzmir、トルコ（Türkiye）、35620
- Izmir Katip Celebi University Ataturk Training and Research Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
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Participants received routine outpatient follow-up care without structured bladder training during the study period.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Urinary Incontinence Severity
時間枠：Baseline and Week 8
|
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI).
Higher scores indicate greater urinary incontinence severity.
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Baseline and Week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Urine Loss
時間枠：Baseline and Week 8
|
Objective urine loss was measured using the standardized one-hour Pad Test.
|
Baseline and Week 8
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Urinary Symptom Distress
時間枠：Baseline and Week 8
|
Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).
|
Baseline and Week 8
|
協力者と研究者
捜査官
- 主任研究者：Perihan Çetin、Izmir Katip Celebi University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2022-GOKAE-0250
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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