Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy
2026年8月17日 更新者：Ya-Wel Chu、Far Eastern Memorial Hospital
Tactile Feedback on Pelvic Floor Muscle Training in the 3rd Trimester of Pregnancy to Prevent of Stress Urinary Incontinence and Its Influence on Biological and Psychological Symptoms
Pregnancy involves significant physiological changes, such as hormone fluctuations, weight gain, and fetal growth, which can affect multiple organ systems. These changes often lead to symptoms like stress urinary incontinence (SUI) and may worsen existing conditions. SUI affects about one-third of pregnant women and can decrease quality of life.
Pelvic floor muscle exercise (PFME) is a recommended treatment to manage urinary incontinence during pregnancy and postpartum. This study aims to compare the effectiveness of three interventions: routine health education, traditional PFME, and tactile feedback PFME, on reducing SUI symptoms, shortening the second stage of labor, and improving quality of life.
Participants will be enrolled in their third trimester and randomly assigned to one of the three groups, with each intervention lasting 8 weeks. Outcome measures include urinary symptoms (via bladder diary, UDI-6, and IIQ-7), quality of life (via KHQ and WHOQOL-BREF), and labor outcomes (duration of the second stage).
調査の概要
状態
完了
詳細な説明
This study compares the effectiveness of three interventions-routine health education, traditional pelvic floor muscle exercise (PFME), and tactile feedback PFME-in improving urinary incontinence in pregnant women.
Participants will receive one of these interventions over 8 weeks during the third trimester.
The primary outcome measures include changes in urinary incontinence symptoms, quality of life,and the duration of the second stage of labor.
Participants will be evaluated at baseline and 8 weeks post-intervention.
This study also aims to determine whether tactile feedback PFME is more effective than traditional PFME or routine health education in reducing urinary incontinence symptoms and improving labor outcomes.
研究の種類
介入
入学 (実際)
141
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Banqiao Dist
-
New Taipei City、Banqiao Dist、台湾
- Far Eastern Memorial Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Pregnant women diagnosed with urinary incontinence by obstetricians or gynecologists during prenatal care.
- Women aged 20 years or older.
- Pregnant at 29 weeks of gestation.
- Singleton pregnancy with cephalic presentation.
- Anticipated vaginal delivery.
- Able to communicate and complete questionnaires without difficulty.
- Willing to participate and provide informed consent.
Exclusion Criteria:
- Diagnosed with high-risk pregnancy or at risk of preterm labor.
- Visual impairment or physical disability that limits participation.
- Currently taking medication for urinary incontinence during pregnancy.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：防止
- 割り当て：非ランダム化
- 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 |
|---|---|
|
プラセボコンパレーター：Basic Health Education Group
Participants in this group receive a one-time, written health education leaflet, without any physical or in-person instruction.
The leaflet includes information on the occurrence and causes of urinary incontinence during pregnancy, dietary recommendations, weight management, and illustrated instructions for Kegel exercises.
|
One-way, one-time health education leaflets are provided for written teaching, with only explanations but no physical teaching.
The content of the health education leaflets includes urinary incontinence during pregnancy, its causes, daily diet, weight control, and Kegel exercise execution methods and movements.
|
|
アクティブコンパレータ：Kegel Exercise Group
Participants in this group receive four in-person sessions of conventional pelvic floor muscle training (PFMT) over an 8-week period.
The training is delivered through interactive, hands-on teaching methods, incorporating posture positioning, guided breathing techniques, and imagery-based instructions (e.g., "closing the door," squeezing the buttocks) to enhance awareness and execution of Kegel contractions.
|
"Four in-person traditional pelvic floor muscle training sessions are scheduled over an eight-week period.
The training involves interactive, hands-on teaching that incorporates body positioning, guided breathing, and the 'closing and opening gate' theory.
This includes imagery techniques such as buttock squeezing and simulating the action of stopping urine flow to facilitate pelvic floor muscle contractions.
|
|
実験的：Sensorimotor-Enhanced PFMT
This group receives sensorimotor-enhanced pelvic floor muscle training (PFMT) in four in-person sessions over an 8-week period.
The training incorporates interactive instruction with body positioning, guided deep breathing, and finger-based tactile feedback.
Participants are guided to sense the lift and contraction of their pelvic floor muscles through palpation techniques, aiming to enhance muscle awareness and neuromuscular coordination.
|
There are four physical tactile pelvic floor muscle training courses arranged in eight weeks.
The training process adopts two-way interactive practical teaching, using movement positioning and deep breathing to induce adjustment of the upper and lower strength of the pelvic floor, and using finger tactile feedback to feel the muscles lifting and contracting up and down during training.
|
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 Symptoms (Bladder Diary)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Mean number of normal voiding episodes per day, urinary incontinence episodes per day, urinary urgency episodes per day, and mean daily fluid intake recorded using a 3-day bladder diary.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Urinary Symptom Distress (UDI-6)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Total score measured using the Urinary Distress Inventory-6 (UDI-6).
Scores range from 0 to 100, with higher scores indicating greater urinary symptom distress.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Incontinence Impact on Daily Life (IIQ-7)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Total score measured using the Incontinence Impact Questionnaire-7 (IIQ-7).
Scores range from 0 to 100, with higher scores indicating greater impact of urinary incontinence on daily activities.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Urinary Incontinence-Related Quality of Life (KHQ)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Domain scores measured using the King's Health Questionnaire (KHQ), including General Health Perception, Role Limitation, Physical Limitation, Social Limitation, Personal Relationships, Emotions, Sleep/Energy, and Severity Measures.
Scores range from 0 to 100, with higher scores indicating poorer quality of life.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Global Quality of Life (WHOQOL-BREF Taiwan Version)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Total score measured using the WHOQOL-BREF Taiwan Version.
Higher scores indicate better quality of life.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI-SF)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Scores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Brief Pain Inventory(BPI)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Scores range from 0 to 10, with higher scores indicating greater pain severity or greater interference with daily activities.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of Second Stage of Labor
時間枠：At delivery
|
Duration of the second stage of labor obtained from medical records.
|
At delivery
|
|
The Pittsburgh Sleep Quality Index (PSQI)
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
|
Pelvic Floor Muscle Exercise Self-Efficacy Scale
時間枠：Baseline, 4 weeks, and 8 weeks post-intervention
|
Scores range from 17 to 85, with higher scores indicating greater self-efficacy for performing pelvic floor muscle exercises.
|
Baseline, 4 weeks, and 8 weeks post-intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年3月8日
一次修了 (実際)
2025年5月5日
研究の完了 (実際)
2025年5月5日
試験登録日
最初に提出
2025年5月27日
QC基準を満たした最初の提出物
2026年6月19日
最初の投稿 (実際)
2026年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 111302-F
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?
いいえ
IPD プランの説明
Based on personal data privacy
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
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。