NCT03274700

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 7, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 27, 2017

Last Update Submit

September 5, 2017

Conditions

Ureteric Stone

Outcome Measures

Primary Outcomes (1)

  • 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.

    1year

Study Arms (2)

Group 1: Patients receive tamsulosin

ACTIVE COMPARATOR

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 receive placebo.

PLACEBO COMPARATOR

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.

Interventions

Tamsulosin.DRUG

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

Group 1: Patients receive tamsulosin
Placebo.DRUG

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

Patients receive placebo.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 15748331BACKGROUND

  • 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.

    PMID: 27616037BACKGROUND

  • 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.

    PMID: 15879806BACKGROUND

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Central Study Contacts

mahmoud eldardery, resident

CONTACT

01008763519meldardery91@gmail.com

ahmed elderwy, professor

CONTACT

01063544453ahmad.elderwy@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

August 27, 2017

First Posted

September 7, 2017

Study Start

October 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

September 7, 2017

Record last verified: 2017-08