Ureteral Calculi
Conditions
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
Interventions
One tablet OD for a maximum of 28 days
OTHERPlacebo
One tablet OD for a maximum of 28 days
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone expulsion rate and time. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of diclofenac injection used | 28 days |
| Rate of occurrence of adverse events | 28 days |
Countries
Thailand
Contacts
Primary ContactBannakij Lojanapiwat, M.D.
Outcome results
None listed