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Trial record 2 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

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

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ClinicalTrials.gov Identifier: NCT03274700
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
mahmoud eldardery, 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).


Condition or disease Intervention/treatment Phase
Ureteric Stone Drug: Tamsulosin. Drug: Placebo. Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

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

Placebo Comparator: 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.

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




Primary Outcome Measures :
  1. Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones. [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274700


Contacts
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Contact: mahmoud eldardery, resident 01008763519 meldardery91@gmail.com
Contact: ahmed elderwy, professor 01063544453 ahmad.elderwy@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: mahmoud eldardery, resident, Assiut University
ClinicalTrials.gov Identifier: NCT03274700     History of Changes
Other Study ID Numbers: tamsulosin in ureteric stones
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Adrenergic Antagonists
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents