Jämförelse av Mirabegron och Tamsulosin för urinstensutdrivning
En randomiserad kontrollerad studie som jämför Mirabegron och Tamsulosin för urinstensutdrivning och förbättring av kliniska symtom
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Shu-Yu Wu, Doctor of Medicine
- Telefonnummer: 60146 +886-2-6628-9779
- E-post: nobookrain2014@gmail.com
Studieorter
-
-
-
New Taipei City, Taiwan, 231
- Rekrytering
- Taipei Tzu Chi Hospital
-
Kontakt:
- Shu-Yu Wu, MD
- Telefonnummer: 60146 +886-2-6628-9779
- E-post: nobookrain2014@gmail.com
-
Kontakt:
- WAN-LING YOUNG, Bachelor of Science in Nursing
- Telefonnummer: 64124 +886-2-6628-9779
- E-post: lisayoung1345@gmail.com
-
Huvudutredare:
- Shu-Yu Wu, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group A: Mirabegron
Patients receive Mirabegron 50 mg daily. |
50 mg tablet orally once daily. |
|
Aktiv komparator: Group B: Tamsulosin
Patients receive Tamsulosin 0.4 mg daily. |
0.4 mg tablet orally once daily. |
|
Experimentell: 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. |
|
Inget ingripande: Group D: Standard of Care
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stone Expulsion Rate
Tidsram: Up to 4 weeks
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Stone Expulsion
Tidsram: Up to 4 weeks
|
The number of days from randomization to the confirmation of complete stone expulsion. |
Up to 4 weeks
|
|
Change in Pain Intensity
Tidsram: Baseline and up to 4 weeks
|
Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
Baseline and up to 4 weeks
|
|
Total Analgesic Consumption
Tidsram: Up to 4 weeks
|
The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain. |
Up to 4 weeks
|
|
Change in Fatigue Symptoms
Tidsram: Baseline and up to 4 weeks
|
Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue. |
Baseline and up to 4 weeks
|
|
Incidence of Adverse Events
Tidsram: Up to 4 weeks
|
Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. |
Up to 4 weeks
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Shu-Yu Wu, MD, Taichung Tzu Chi Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Calculi
- Patologiska tillstånd, anatomiska
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urolithiasis
- Urinvägar
- Ureterala sjukdomar
- Patologiska tillstånd, tecken och symtom
- Ureterolithiasis
- Ureteral Calculi
- Svavelföreningar
- Organiska kemikalier
- Kolväten
- Kolväten, cykliska
- Kolväten, aromatisk
- Amider
- Bensiverivat
- Bensensulfonamider
- Sulfonamider
- Sulfoner
- Tamsulosin
- mirabegron
Andra studie-ID-nummer
- 14-IRB074
- TCRD-TPE-115-35 (Annat bidrag/finansieringsnummer: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
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