요관 결석 배출을 위한 미라베그론과 탐술로신의 비교
요관 결석 배출 및 임상 증상 개선을 위한 미라베그론과 탐술로신 비교 무작위 대조 시험
This randomized controlled trial compares the efficacy and safety of four treatment strategies for ureteral stone expulsion: Mirabegron alone, Tamsulosin alone, a combination of both, and standard conservative care. Participants diagnosed with ureteral stones will be randomly assigned to one of these four groups. The primary objective is to evaluate the stone expulsion rate within 4 weeks. The study also assesses time to expulsion, pain intensity, analgesic use, and potential side effects.
연구 개요
상세 설명
This study aims to compare the efficacy of Mirabegron, Tamsulosin, their combination, and standard conservative management in facilitating ureteral stone expulsion, as well as to evaluate their impact on clinical symptoms.
The primary objective is to analyze the differences in the stone expulsion rate within four weeks among four treatment groups:
Group A: Mirabegron 50 mg daily.
Group B: Tamsulosin 0.4 mg daily.
Group C: Combination of Mirabegron 50 mg and Tamsulosin 0.4 mg daily.
Group D: Standard of care (symptomatic control). For acute colic, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ketorolac or Diclofenac are the first-line treatment. If patients have allergies or contraindications to NSAIDs, alternative analgesics such as Tramadol or Acetaminophen will be administered.
Secondary objectives include comparing the time to stone expulsion, changes in pain intensity (assessed by Visual Analog Scale), consumption of analgesic medication, and the impact of different treatments on patient fatigue (assessed by the Fatigue Symptom Inventory, FSI).
Additionally, the study will collect and analyze adverse events occurring during the treatment period, such as palpitations, blood pressure changes, and headaches, to evaluate the safety of each intervention. The results are expected to provide comprehensive options for Medical Expulsive Therapy (MET), offering alternative non-invasive strategies for patients intolerant to traditional alpha-blockers.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Shu-Yu Wu, Doctor of Medicine
- 전화번호: 60146 +886-2-6628-9779
- 이메일: nobookrain2014@gmail.com
연구 장소
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New Taipei City, 대만, 231
- 모병
- Taipei Tzu Chi Hospital
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연락하다:
- Shu-Yu Wu, MD
- 전화번호: 60146 +886-2-6628-9779
- 이메일: nobookrain2014@gmail.com
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연락하다:
- WAN-LING YOUNG, Bachelor of Science in Nursing
- 전화번호: 64124 +886-2-6628-9779
- 이메일: lisayoung1345@gmail.com
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수석 연구원:
- Shu-Yu Wu, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age and Sex: Adult patients aged 18 to 75 years, inclusive of both males and females.
- Diagnosis: Unilateral ureteral stone confirmed by Computed Tomography (CT), Renal Sonography, or Kidney-Ureter-Bladder (KUB) radiography.
- Stone Characteristics: Stone size between 4 mm and 10 mm; located in the upper (proximal), middle, or lower (distal) ureter.
- Symptoms and Renal Function: Presence of renal colic or hematuria, with no severe renal insufficiency (eGFR > 60 mL/min/1.73m²).
Exclusion Criteria:
- Urinary tract infection (UTI).
- Multiple or bilateral ureteral stones.
- Ureteral stones not visible on KUB radiography (radiolucent stones).
- Pregnant or lactating women.
- Severe hydronephrosis.
- Renal insufficiency (defined as eGFR < 30 mL/min/1.73m² or Serum Creatinine > 2 mg/dL).
- Uncontrolled hypertension or major cardiovascular disease.
- Patients who refuse Medical Expulsive Therapy (MET).
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 |
|---|---|
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실험적: Group A: Mirabegron
Patients receive Mirabegron 50 mg daily. |
50 mg tablet orally once daily. |
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활성 비교기: Group B: Tamsulosin
Patients receive Tamsulosin 0.4 mg daily. |
0.4 mg tablet orally once daily. |
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실험적: Group C: Combination
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily. |
50 mg tablet orally once daily. 0.4 mg tablet orally once daily. |
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간섭 없음: Group D: Standard of Care
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stone Expulsion Rate
기간: Up to 4 weeks
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The proportion of participants with complete stone expulsion confirmed by KUB or CT scan. Successful expulsion is defined as the absence of stone fragments or the presence of clinically insignificant fragments. |
Up to 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Stone Expulsion
기간: Up to 4 weeks
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The number of days from randomization to the confirmation of complete stone expulsion. |
Up to 4 weeks
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Change in Pain Intensity
기간: Baseline and up to 4 weeks
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Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
Baseline and up to 4 weeks
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Total Analgesic Consumption
기간: Up to 4 weeks
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The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain. |
Up to 4 weeks
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Change in Fatigue Symptoms
기간: Baseline and up to 4 weeks
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Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue. |
Baseline and up to 4 weeks
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Incidence of Adverse Events
기간: Up to 4 weeks
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Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. |
Up to 4 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shu-Yu Wu, MD, Taichung Tzu Chi Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 14-IRB074
- TCRD-TPE-115-35 (기타 보조금/기금 번호: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared to protect patient confidentiality. All relevant data will be reported in the final study publication in aggregate form.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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