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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones

NCT01167062

Ureteral Calculi

UNKNOWN PHASE4

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

NCT00600405

Nephrolithiasis Ureteral Calculi

COMPLETED NA

Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

NCT00762424

Kidney Stone

COMPLETED NA

Evaluation of Tamsulosin in the Treatment of Ureteral Stones

NCT00151567

Ureterolithiasis Ureteral Calculi

COMPLETED PHASE3

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

NCT00448123

Kidney Stones Ureteral Stones

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteric Stone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Patients receive 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.

Group Type ACTIVE_COMPARATOR

Tamsulosin.

Intervention Type DRUG

Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.

Patients receive 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 Type PLACEBO_COMPARATOR

Placebo.

Intervention Type DRUG

Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tamsulosin.

Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.

Intervention Type DRUG

Placebo.

Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes