NCT05032287

Brief Summary

To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 25, 2021

Last Update Submit

August 30, 2021

Conditions

Urologic DiseasesUrolithiasisStone, Kidney

Outcome Measures

Primary Outcomes (1)

  • Stone free rate defined as patient free of any stone residual

    assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT)

    at 3 months

Study Arms (2)

tamsulosin

ACTIVE COMPARATOR

tamsulosin 0.4 mg once daily

Drug: Tamsulosin

Placeb

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

TamsulosinDRUG

Tamsulosin 0.4 mg once daily

tamsulosin
PlaceboDRUG

Placebo once daily

Placeb

Eligibility Criteria

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

You may qualify if:

  • Renal stone ≤ 20 mm.
  • Lower calyceal stone ≤ 15 mm

You may not qualify if:

  • Women with known or suspected pregnancy or breastfeeding.
  • History of alpa-blockers (more than 7 days prior to study participation)
  • History of ureteral stricture
  • Multiple (that is more than 2) stones
  • Stone in solitary kidney (either anatomically or functionally).
  • Presence of urinary sepsis.
  • Estimated glomerular filtration rate \< 30 ml/min
  • Contraindication or allergy to tamsulosin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urologic DiseasesUrolithiasisKidney Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 2, 2021

Study Start

September 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

EG(1)