Moxibustion for Nocturia
2026年5月17日 更新者：Buddhist Tzu Chi General Hospital
Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night.
Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions.
This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
調査の概要
詳細な説明
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night.
Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions.
This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
Using voiding diaries, the International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS), and Quality of Life (QoL) assessments, this study aimed to provide a cost-effective and clinically feasible complementary and alternative therapy.
Furthermore, the TCM constitutional characteristics of nocturia patients were analyzed through the Constitution in Chinese Medicine Questionnaire (CCMQ) combined with evaluations of abdominal muscle tension.
研究の種類
介入
入学 (推定)
100
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。
研究連絡先
- 名前：Yen-Lun Kung
- 電話番号：+886-3-8561825
- メール：kung818@gmail.com
研究場所
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Hualien City、台湾
- 募集
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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コンタクト：
- Yen-Lun Kung
- メール：kung818@gmail.com
-
-
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
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Patients aged 40 years or older.
- Experiencing two or more nocturia episodes per night.
Exclusion Criteria
- Active urinary tract infection (UTI).
- Poorly controlled diabetes mellitus (defined as HbA1c > 6.5%).
- Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.
- Severe congestive heart failure (New York Heart Association [NYHA] functional class > II).
- Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).
- Pregnant women.
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：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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール
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実験的：お灸
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Apply moxibustion on acupoint
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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 |
時間枠 |
|---|---|
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frequency of nocturia
時間枠：Baseline and Week 3 and Week 6
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Baseline and Week 3 and Week 6
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nocturnal urine volume
時間枠：Baseline and Week 3 and Week 6
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Baseline and Week 3 and Week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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International Prostate Symptom Score (IPSS)
時間枠：Baseline and Week 3 and Week 6
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Total score on the International Prostate Symptom Score (IPSS).
The scale ranges from 0 to 35, where higher scores indicate more severe symptoms (worse outcome).
|
Baseline and Week 3 and Week 6
|
|
Overactive Bladder Symptom Score (OABSS)
時間枠：Baseline and Week 3 and Week 6
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Total score on the Overactive Bladder Symptom Score (OABSS).
The OABSS is a four-item questionnaire assessing daytime frequency, nighttime frequency, urgency, and urgency incontinence.
The total score ranges from 0 to 15, where higher scores indicate more severe overactive bladder symptoms (worse outcome).
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Baseline and Week 3 and Week 6
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Quality of Life (QoL)
時間枠：Baseline and Week 3 and Week 6
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The International Prostate Symptom Score (IPSS) Quality of Life (QoL) is a single-item questionnaire that assesses the patient's perceived satisfaction with their current urinary symptoms.
Patients answer the question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?"
The score ranges from 0 to 6, where 0 represents "delighted" and 6 represents "terrible."
A higher score indicates a poorer quality of life (worse outcome).
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Baseline and Week 3 and Week 6
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Pittsburgh Sleep Quality Index (PSQI)
時間枠：Baseline and Week 3 and Week 6
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The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess sleep quality over a one-month time interval.
It consists of 19 individual items which are used to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of these seven component scores yields one global score.
The global PSQI score ranges from 0 to 21, where 0 indicates no difficulty and 21 indicates severe difficulties in all areas.
A higher score indicates poorer sleep quality (worse outcome).
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Baseline and Week 3 and Week 6
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Abdominal muscle tension
時間枠：Baseline and Week 3 and Week 6
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Muscle tone (tension) is measured using the MyotonPRO digital palpation device.
The frequency (F) is calculated based on the oscillations of the muscle tissue after a mechanical impulse.
The unit of measure is Hertz (Hz).
A higher frequency indicates higher muscle tone (increased tension), which in the context of this study represents a worse outcome (abdominal tension).
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Baseline and Week 3 and Week 6
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Abdominal muscle stiffness
時間枠：Baseline and Week 3 and Week 6
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Dynamic stiffness (S) is measured using the MyotonPRO digital palpation device.
Stiffness (S) represents the ability of the muscle tissue to resist an external force.
The unit of measure is Newtons per meter (N/m).
A higher value indicates a stiffer or more rigid muscle, representing a worse outcome (increased abdominal rigidity).
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Baseline and Week 3 and Week 6
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Abdominal muscle elasticity
時間枠：Baseline and Week 3 and Week 6
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Muscle elasticity is measured using the MyotonPRO digital palpation device.
The logarithmic decrement (D) represents the muscle's ability to recover its shape after deformation (elasticity).
This is a dimensionless value.
A higher decrement value indicates lower elasticity and a longer recovery time, representing a worse outcome (reduced tissue elasticity).
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Baseline and Week 3 and Week 6
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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)
2025年1月1日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年3月4日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月17日
最終確認日
2026年3月1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
- IRB114-009-A
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
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