Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities.
This study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure.
Symptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements.
The results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.
調査の概要
状態
詳細な説明
Overactive bladder (OAB) is a prevalent urological condition characterized by urinary urgency, frequency, and nocturia, which significantly impairs quality of life. Emerging evidence suggests a strong association between OAB and metabolic syndrome, which is characterized by insulin resistance, hypertension, dyslipidemia, and central obesity. These metabolic abnormalities may contribute to endothelial dysfunction, chronic inflammation, and autonomic dysregulation, potentially affecting bladder function.
Low-energy extracorporeal shock wave therapy (LiESWT) is a novel, non-invasive therapeutic modality that has been shown to promote angiogenesis, improve tissue perfusion, and modulate inflammatory responses. Previous studies have demonstrated its potential benefits in various urological conditions.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the efficacy and safety of LiESWT in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either LiESWT treatment or a sham procedure.
Clinical outcomes are assessed using validated patient-reported outcome measures, including OABSS, ICIQ-SF, UDI-6, and IIQ-7, along with objective parameters such as uroflowmetry and post-void residual volume. Assessments are performed at baseline and at multiple follow-up time points after treatment.
This study aims to provide clinical evidence on the therapeutic role of LiESWT in improving symptoms and quality of life in this specific patient population.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：JIUNHUNG GENG, MD
- 電話番号：+88673121101 ext.6694
- メール：u9001090@hotmail.com
研究連絡先のバックアップ
- 名前：Yung-Chin Lee, MD, PHD
- 電話番号：+88673121101 ext.6694
- メール：leeyc12345@yahoo.com.tw
研究場所
-
-
Taiwan
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Kaohsiung、Taiwan、台湾、807
- 募集
- Kaohsiung Medical University
-
コンタクト：
- JIUNHUNG GENG, MD
- 電話番号：+88673121101 ext 6694
- メール：u9001090@hotmail.com
-
コンタクト：
- Yung-Chin Lee, MD,PHD
- 電話番号：+88673121101
- メール：leeyc12345@yahoo.com.tw
-
副調査官：
- Jiun-Hung Geng, MD
-
-
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:
- Female participants aged 20 to 75 years
- Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months
- Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
- Waist circumference ≥80 cm
- Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment
- Fasting glucose ≥100 mg/dL or receiving treatment for diabetes
- Triglycerides ≥150 mg/dL or receiving lipid-lowering treatment
- High-density lipoprotein cholesterol <50 mg/dL
- No pharmacological or injection treatment for OAB within 3 months prior to enrollment
- Able to understand and comply with study procedures and questionnaires
- Willing to provide informed consent
Exclusion:
- History of kidney stones or bladder stones
- Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes)
- Lower urinary tract surgery within 6 months prior to enrollment
- Known or suspected malignancy of the urinary tract
- Significant bladder outlet obstruction
- Severe coagulopathy, liver failure, or renal failure
- Prior pelvic malignancy or pelvic radiation therapy
- Intravesical injection or electrical stimulation therapy within the past year
- Substance abuse (drug or alcohol) within the past year
- Chronic pelvic pain due to other causes
- Inability to complete study questionnaires or procedures
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
|
LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session.
|
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偽コンパレータ：Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
|
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
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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 |
|---|---|---|
|
Change in Overactive Bladder Symptom Score (OABSS)
時間枠：Baseline to 24 weeks
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The Overactive Bladder Symptom Score (OABSS; range 0-15, with higher scores indicating more severe symptoms) will be used.
The primary outcome is the change in OABSS from baseline to 4, 8, 12, 16, 20, 24 weeks after treatment.
Lower scores indicate improvement in symptoms.
|
Baseline to 24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
時間枠：Baseline to 24 weeks
|
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms).
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Baseline to 24 weeks
|
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Change in Urinary Distress Inventory (UDI-6)
時間枠：Baseline to 24 weeks
|
The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress).
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Baseline to 24 weeks
|
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Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
時間枠：Baseline to 24 weeks
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Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry.
Higher values indicate improved urinary flow function.
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Baseline to 24 weeks
|
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Change in post-void residual volume measured by bladder ultrasound (PVR)
時間枠：Baseline to 24 weeks
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Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding.
Lower values indicate improved bladder emptying.
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Baseline to 24 weeks
|
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Change in voided volume per micturition assessed by 3-day voiding diary
時間枠：Baseline to 24 weeks
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Voided volume (mL) will be calculated from a 3-day voiding diary.
Higher values indicate improved bladder capacity.
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Baseline to 24 weeks
|
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Change in total daily urine volume assessed by 3-day voiding diary
時間枠：Baseline to 24 weeks
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Total urine volume (mL/day) will be calculated from a 3-day voiding diary.
|
Baseline to 24 weeks
|
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change in Incontinence Impact Questionnaire short version (IIQ-7)
時間枠：Baseline to 24 weeks
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The IIQ-7 uses a 0-3 scale to measure how urinary incontinence impacts household chores, physical recreation, entertainment, travel, social activities, emotional health, and feelings of frustration to determine an overall quality-of-life score.
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Baseline to 24 weeks
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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 |
|---|---|---|
|
Incidence of treatment-related adverse events
時間枠：Baseline to 24 weeks
|
Adverse events will be recorded throughout the study period and classified according to severity and relationship to treatment.
|
Baseline to 24 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Yung-Chin Lee, MD,PHD、Kaohsiung Medical University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- KMUHIRB-F(I)-20230051
- KMUH-LiESWT-OAB-2023 (その他の識別子：Kaohsiung Medical University Hospital)
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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