Sammenligning av Mirabegron og Tamsulosin for utstøting av urinstein
En randomisert kontrollert studie som sammenligner Mirabegron og Tamsulosin for utstøting av urinrørstein og klinisk symptomforbedring
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Shu-Yu Wu, Doctor of Medicine
- Telefonnummer: 60146 +886-2-6628-9779
- E-post: nobookrain2014@gmail.com
Studiesteder
-
-
-
New Taipei City, Taiwan, 231
- Rekruttering
- Taipei Tzu Chi Hospital
-
Ta kontakt med:
- Shu-Yu Wu, MD
- Telefonnummer: 60146 +886-2-6628-9779
- E-post: nobookrain2014@gmail.com
-
Ta kontakt med:
- WAN-LING YOUNG, Bachelor of Science in Nursing
- Telefonnummer: 64124 +886-2-6628-9779
- E-post: lisayoung1345@gmail.com
-
Hovedetterforsker:
- Shu-Yu Wu, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Ingen inngripen: Group D: Standard of Care
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stone Expulsion Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Stone Expulsion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 4 weeks
|
Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. |
Up to 4 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Shu-Yu Wu, MD, Taichung Tzu Chi Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Mannlige urogenitale sykdommer
- Calculi
- Patologiske tilstander, anatomiske
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Urolithiasis
- Urinkalkuli
- Ureteriske sykdommer
- Patologiske tilstander, tegn og symptomer
- Ureterolithiasis
- Ureterkalkuli
- Svovelforbindelser
- Organiske kjemikalier
- Hydrokarboner
- Hydrokarboner, syklisk
- Hydrokarboner, aromatisk
- Amides
- Benzenderivater
- Benzenesulfonamider
- Sulfonamider
- Sulfoner
- Tamsulosin
- Mirabegron
Andre studie-ID-numre
- 14-IRB074
- TCRD-TPE-115-35 (Annet stipend/finansieringsnummer: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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