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

NCT05725122 | Completed

• 1 other identifier: S23
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• stone clearance

  Number of patients cleared from ureteric stones

  4 weeks

Study Arms (2)

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

Extracorporeal shock wave lithotripsy PROCEDURE

Extracorporeal shock wave lithotripsy will given to the patients

ESWL alone

Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy. PROCEDURE

Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients

ESWL combined with tamsulosin therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• single upper ureteric stone
• size ranging from 6-15 mm
• stones history less than 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

PA (1)