Upper Tract Ureterolithiasis Clinical Trial
Official title:
Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
| NCT number | NCT00478998 |
| Other study ID # | 890pal- HMO-CTIL |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 2 |
| First received | May 24, 2007 |
| Last updated | May 24, 2007 |
The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .
| Status | Not yet recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients above 18 yrs of age. - Single urolithiasis up to 2 cm. - Kidney/ureters that haven't undergone previous ESWL or stent insertion. - Normal renal function (creatinine below 100mmo1/1). - Sterile urine culture. - Normal CBC, blood electrolytes and coagulation studies. - Radioopaque stones. Exclusion Criteria: - More than one stone per kidney unit. - Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis. - Anatomical anomalies or uromechanical obstruction. - Single kidney. - Cystinuria. - Soldiers or pregnant women. - Patients under 18 year |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | stone status at 3 month . | |||
| Primary | stone free |