Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
Phase 4
- Conditions
- Ureteral Calculi
- Interventions
- Other: Placebo
- Registration Number
- NCT01167062
- Lead Sponsor
- Chiang Mai University
- Brief Summary
This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.
- Detailed Description
* patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
* All patients will receive 75 mg sodium diclofenac via intramuscular on demand
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Male or female patient aged => 18 years.
- Patients who have distal ureteral stones with a size of 4-10 mm
- Written informed consent has been obtained.
Exclusion Criteria
- Patients with history of ureteral surgery
- Patients with urinary tract infection
- Patient with diabetes and peptic ulcer
- Patient with renal dysfunction (elevated of serum creatinine level)
- Patients with severe hydronephrosis
- Patients with history of passing stones
- Pregnancy
- Patients who desire to withdraw from the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Tamsulosin Hydrochloride OCAS 0.4 mg Tamsulosin Hydrochloride OCAS 0.4 mg -
- Primary Outcome Measures
Name Time Method Stone expulsion rate and time. 28 days
- Secondary Outcome Measures
Name Time Method Number of diclofenac injection used 28 days Rate of occurrence of adverse events 28 days
Trial Locations
- Locations (1)
Maharat Nakhon Chiangmai Hospital
🇹ðŸ‡Muang, Chiangmai, Thailand