Stone Clearance in Patients With Upper Ureteric Stones Us... | NCT05725122

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

NCT05725122

Sponsor

Services Hospital, Lahore

Status

Completed

Last Update Posted

Feb 13, 2023Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Renal Stone

Interventions

Extracorporeal shock wave lithotripsy
Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Feb 2, 2023

First Submission Date that Met QC Criteria

Feb 10, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2023

Last Update Posted Date

Feb 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESWL alone	Active Comparator	Extracorporeal shock wave lithotripsy will be given to the patient	Procedure: Extracorporeal shock wave lithotripsy
ESWL combined with tamsulosin therapy	Active Comparator	Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient	Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extracorporeal shock wave lithotripsy	Procedure	Extracorporeal shock wave lithotripsy will given to the patients	ESWL alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stone clearance	Number of patients cleared from ureteric stones	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
services Institute of Medical Sciences		Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052878	Urolithiasis
D052801	Male Urogenital Diseases

ID	Term
D013812	Therapeutics
D059708	Ultrasonic Surgical Procedures
D013514	Surgical Procedures, Operative