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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
İzmir
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Izmir, İzmir, 터키 (Türkiye), 35620
- Izmir Katip Celebi University Ataturk Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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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.
|
|
활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Urinary Incontinence Severity
기간: Baseline and Week 8
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Urine Loss
기간: Baseline and Week 8
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Objective urine loss was measured using the standardized one-hour Pad Test.
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Baseline and Week 8
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Urinary Symptom Distress
기간: Baseline and Week 8
|
Urinary symptom distress was evaluated using the Urogenital Distress Inventory (UDI-6).
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Baseline and Week 8
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공동 작업자 및 조사자
수사관
- 수석 연구원: Perihan Çetin, Izmir Katip Celebi University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2022-GOKAE-0250
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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