The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms

Early Phase 1

• Conditions: Ureteric Stone
• Interventions: Drug: Placebo.; Drug: Tamsulosin.

• Registration Number: NCT03274700
• Lead Sponsor: Assiut University

Brief Summary

To estimate the efficacy of tamsulosin in:

A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).

B - Pain relief and hyronephrosis improvement (secondary goal).

Detailed Description

Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .

Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .

The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .

The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-09-05
• Last Update Submitted: 2017-09-05
• Study First Posted: 2017-09-07
• Last Update Posted: 2017-09-07
• Study Start: 2017-10-01
• Primary Completion: 2018-09
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Lower ureteric stones from(10-15) mm diameters.
2. Age group equal or more than 18 years.
3. Normal renal function.

Exclusion Criteria

1. Lower ureteric stones less than 10mm and more than 15 mm diameters.
2. Age group less than 18 years.
3. Associated ureteric strictures.
4. Febrile urinary tract infections.
5. Severe hydronephrosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receive placebo.	Placebo.	Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Group 1: Patients receive tamsulosin	Tamsulosin.	Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.

Primary Outcome Measures

Name	Time	Method
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.	1year	Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones.; At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones.; At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.