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Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

Primary Purpose

Renal Stone

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Extracorporeal shock wave lithotripsy
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: single upper ureteric stone size ranging from 6-15 mm stones history less than 6 months Exclusion Criteria: Patients with urinary tract infection multiple ureteric stones, presence of a ureteric stricture distal to the stone, previous unsuccessful ESWL, concomitant use of calcium channel blockers or alpha-adrenergic antagonists patients with abnormal coagulation profile

Sites / Locations

  • services Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESWL alone

ESWL combined with tamsulosin therapy

Arm Description

Extracorporeal shock wave lithotripsy will be given to the patient

Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient

Outcomes

Primary Outcome Measures

stone clearance
Number of patients cleared from ureteric stones

Secondary Outcome Measures

Full Information

First Posted
February 2, 2023
Last Updated
February 10, 2023
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05725122
Brief Title
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
Official Title
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

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

5. Study Description

Brief Summary
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWL alone
Arm Type
Active Comparator
Arm Description
Extracorporeal shock wave lithotripsy will be given to the patient
Arm Title
ESWL combined with tamsulosin therapy
Arm Type
Active Comparator
Arm Description
Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shock wave lithotripsy
Intervention Description
Extracorporeal shock wave lithotripsy will given to the patients
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
Intervention Description
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients
Primary Outcome Measure Information:
Title
stone clearance
Description
Number of patients cleared from ureteric stones
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single upper ureteric stone size ranging from 6-15 mm stones history less than 6 months Exclusion Criteria: Patients with urinary tract infection multiple ureteric stones, presence of a ureteric stricture distal to the stone, previous unsuccessful ESWL, concomitant use of calcium channel blockers or alpha-adrenergic antagonists patients with abnormal coagulation profile
Facility Information:
Facility Name
services Institute of Medical Sciences
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

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