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

Primary Purpose

Ureteric Stone

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tamsulosin.
Placebo.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteric Stone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group 1: Patients receive tamsulosin

    Patients receive placebo.

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 27, 2017
    Last Updated
    September 5, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03274700
    Brief Title
    The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    September 2018 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ureteric Stone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Patients receive tamsulosin
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Patients receive placebo.
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin.
    Intervention Description
    Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo.
    Intervention Description
    Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
    Primary Outcome Measure Information:
    Title
    Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
    Description
    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.
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Lower ureteric stones from(10-15) mm diameters. Age group equal or more than 18 years. Normal renal function. Exclusion Criteria: Lower ureteric stones less than 10mm and more than 15 mm diameters. Age group less than 18 years. Associated ureteric strictures. Febrile urinary tract infections. Severe hydronephrosis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mahmoud eldardery, resident
    Phone
    01008763519
    Email
    meldardery91@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed elderwy, professor
    Phone
    01063544453
    Email
    ahmad.elderwy@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15748331
    Citation
    Pearle MS. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. Int Braz J Urol. 2004 Nov-Dec;30(6):546-547. No abstract available.
    Results Reference
    background
    PubMed Identifier
    27616037
    Citation
    Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Ann Emerg Med. 2017 Mar;69(3):353-361.e3. doi: 10.1016/j.annemergmed.2016.06.044. Epub 2016 Sep 8.
    Results Reference
    background
    PubMed Identifier
    15879806
    Citation
    Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2. doi: 10.1097/01.ju.0000158453.60029.0a.
    Results Reference
    background

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

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