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

Sponsor

Services Hospital, Lahore (Other)

Overall Status

Completed

CT.gov ID

NCT05725122

Collaborator

(none)

Enrollment

Location

Arms

46.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Renal Stone	Procedure: Extracorporeal shock wave lithotripsy Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESWL alone Extracorporeal shock wave lithotripsy will be given to the patient	Procedure: Extracorporeal shock wave lithotripsy Extracorporeal shock wave lithotripsy will given to the patients
Active Comparator: ESWL combined with tamsulosin therapy Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient	Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy. Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients

Arm

Intervention/Treatment

Active Comparator: ESWL alone

Extracorporeal shock wave lithotripsy will be given to the patient

Procedure: Extracorporeal shock wave lithotripsy

Extracorporeal shock wave lithotripsy will given to the patients

Active Comparator: ESWL combined with tamsulosin therapy

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

Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.

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

Outcome Measures

Primary Outcome Measures

stone clearance [4 weeks]
Number of patients cleared from ureteric stones

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	services Institute of Medical Sciences	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Services Hospital, Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. SamiUllah, Principal Investigator, Services Hospital, Lahore

ClinicalTrials.gov Identifier:

NCT05725122

Other Study ID Numbers:

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023