Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
2021年12月27日 更新者：Taipei Veterans General Hospital, Taiwan
Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
Research question:
A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. The primary aim of this trial is to answer the questions: how does varying the treatment sequence involving mirabegron and transcutaneous tibial nerve stimulation (TTNS) affect efficacy and patient acceptance and what is the second-line efficacy of either treatment modality?
Primary objective:
To evaluate improvement in storage symptoms, as measured by changes in Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS) and parameters of voiding diary, in overactive bladder (OAB) patients receiving mirabegron or TTNS as first-line therapy when crossed over to second-line therapy with the opposite treatment modality
Secondary objectives:
To evaluate improvement in symptoms, as measured by changes in OABSS, IPSS and parameters of voiding diary, on first-line therapy with mirabegron or TTNS followed by combination multi-modal therapy To evaluate the effect of multi-modal treatment approach on patient's perception of treatment satisfaction and symptom control To evaluate urodynamic profiles of patients treated with multi-modal approach
調査の概要
詳細な説明
Study design: Prospective, randomized, multicenter, open-label, cross-over trial Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B
Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks
Patient population: adults ≥ 20 years who have experienced symptoms of OAB, as defined by International Continence Society (ICS) diagnostic criteria, for at least 3 months
Sample size: approximately 180 patients
研究の種類
介入
入学 (予想される)
180
段階
- フェーズ 4
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：Chih-Chieh Lin, MD/Phd
- 電話番号：+886-2-2875-7808
- メール：jayslylin@gmail.com
研究場所
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Taipei City、台湾、11217
- 募集
- Taipei Veterans General Hospital
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コンタクト：
- Chih-Chieh Lin, MD/Phd
- 電話番号：+886-2-2875-7808
- メール：jayslylin@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
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adult OAB patients ≥20 years
- Diagnosed with moderate to severe OAB (with or without urgency incontinence) based on OABSS >5 and clinical assessment, with UUI-predominant presentation, for at least 3 months
- Able to receive TTNS and accommodate treatment logistics (30 min per on-site session, twice weekly)
- Provided informed consent to participate in the study
Exclusion Criteria:
- Neurologic conditions associated with OAB symptoms
- History of stress urinary incontinence
- Use of intravesical onabotulinumoxinA within recent 6 months
- Postvoid residual urine volume (PVR) ≥ 100mL
- Evidence of active urinary tract infection or urinary tract stone at screening
- Genitourinary tract operation during the 3-month period prior to baseline
- Confirmed or suspected genitourinary tract or pelvic malignancy
- History of uncontrolled hypertension (systolic >160 mmHg and/or diastolic >110 mmHg)
- History of intolerance to mirabegron
- Patients with pacemakers or implantable defibrillators
- Patients prone to excessive bleeding
- Patients with nerve damage that could impact percutaneous tibial nerve or pelvic floor function
- Patients who are pregnant or planning to become pregnant during the duration of treatment
- History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
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：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Sequence A
mirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks
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mirabegron 50mg QD
transcutaneous tibial nerve stimulation
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実験的：Sequence B
TTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks
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mirabegron 50mg QD
transcutaneous tibial nerve stimulation
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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 |
|---|---|---|
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Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
時間枠：Baseline and Week 20
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Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome).
Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
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Baseline and Week 20
|
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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Changes from baseline to Week 12 in OABSS
時間枠：Baseline and Week 12
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Changes from baseline to Week 12 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome)
|
Baseline and Week 12
|
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Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS
時間枠：Baseline, and Week 12 and 20
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Changes from baseline in IPSS (International Prostate Symptom Score) at Week 12 and 20 (a lower IPSS represents a better outcome)
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Baseline, and Week 12 and 20
|
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Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 Hours
時間枠：Baseline, and Week 12 and 20
|
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
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Baseline, and Week 12 and 20
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Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 Hours
時間枠：Baseline, and Week 12 and 20
|
Nocturia is defined as waking at night one or more times to void.
The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from a micturition diary in which a patient records for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
|
Baseline, and Week 12 and 20
|
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Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 Hours
時間枠：Baseline, and Week 12 and 20
|
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) is derived from episodes reocrded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
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Baseline, and Week 12 and 20
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Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 Hours
時間枠：Baseline, and Week 12 and 20
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The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
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Baseline, and Week 12 and 20
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Changes from Week 8 to Week 20 in OABSS
時間枠：Week 8 to Week 20
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Changes from Week 8 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
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Week 8 to Week 20
|
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Changes from Week 8 to Week 20 in IPSS
時間枠：Week 8 to Week 20
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Changes from Week 8 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
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Week 8 to Week 20
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Changes from Week 8 to Week 20 in Mean Number of Micturitions per 24 Hours
時間枠：Week 8 to Week 20
|
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
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Week 8 to Week 20
|
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Changes from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
時間枠：Week 8 to Week 20
|
Nocturia is defined as waking at night one or more times to void.
The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
|
Week 8 to Week 20
|
|
Changes from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
時間枠：Week 8 to Week 20
|
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
|
Week 8 to Week 20
|
|
Changes from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
時間枠：Week 8 to Week 20
|
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
|
Week 8 to Week 20
|
|
Changes from Week 12 to Week 20 in OABSS
時間枠：Week 12 to Week 20
|
Changes from Week 12 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
|
Week 12 to Week 20
|
|
Changes from Week 12 to Week 20 in IPSS
時間枠：Week 12 to Week 20
|
Changes from Week 12 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
|
Week 12 to Week 20
|
|
Changes from Week 12 to Week 20 in Mean Number of Micturitions per 24 Hours
時間枠：Week 12 to Week 20
|
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
|
Week 12 to Week 20
|
|
Changes from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
時間枠：Week 12 to Week 20
|
Nocturia is defined as waking at night one or more times to void.
The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
|
Week 12 to Week 20
|
|
Changes from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
時間枠：Week 12 to Week 20
|
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
|
Week 12 to Week 20
|
|
Changes from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
時間枠：Week 12 to Week 20
|
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
|
Week 12 to Week 20
|
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Changes from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
時間枠：Baseline, and Week 12 and 20
|
Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life.
Participants rate each item using a 6-point Likert Scale ranging from "Not at all" to "A very great deal" for the symptom bother items and "none of the time" to "All of the time" for the Health Related Quality of Life (HRQL) items.
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Baseline, and Week 12 and 20
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Changes from baseline to Week 12 and 20/end of treatment (EoT) in Bladder Assessment Tool (BAT) score
時間枠：Baseline, and Week 12 and 20
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Bladder Assessment Tool (BAT) is a participant-reported instrument consisting of 17 questions regarding the symptoms, bothering, impacts and treatment satisfaction in the past 7 days.
Scores range from 0 to 88, a reduction in BAT score indicates an improvement.
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Baseline, and Week 12 and 20
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Changes from baseline to Week 12 and 20/end of treatment (EoT) in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
時間枠：Baseline, and Week 12 and 20
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Treatment Satisfaction-Visual Analog Scale (TS-VAS) is a quantitative instrument assessing participant improvement in participants with OAB.
A score of 10 on the TS-VAS indicates complete satisfaction, whereas a positive change from baseline indicates improvement.
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Baseline, and Week 12 and 20
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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。
捜査官
- 主任研究者：Chih-Chieh Lin, MD/Phd、Taipei Veterans General Hospital, Taiwan
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)
2021年11月10日
一次修了 (予想される)
2023年9月1日
研究の完了 (予想される)
2023年9月1日
試験登録日
最初に提出
2021年11月22日
QC基準を満たした最初の提出物
2021年12月27日
最初の投稿 (実際)
2022年1月12日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月12日
QC基準を満たした最後の更新が送信されました
2021年12月27日
最終確認日
2021年12月1日
詳しくは
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。