Protocol summary

Study aim
To compare the effectiveness of Silodosin and extracorporeal shock wave lithotripsy (ESWL) in patients admitted for management of lower ureteric stone.
Design
Randomized Clinical Trial
Settings and conduct
The trial was double-blind and commenced at the Urology department of LUMHS, Jamshoro from August 2023 to July 2024. Blinding maintenance was ensured by using envelopes/slips that indicate only the group allocation without revealing the intervention details, keeping trial participants, data collectors, and outcome assessors blinded; additionally, interventions were designed to appear identical where feasible, such as in color, consistency, or packaging.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients between the ages of 15-70 years, both gender, and having stone sizes 5-10mm in the lower ureteric region were included. Exclusion Criteria:Patients having a single functional kidney before treatment, previous ureteric surgery, ureteric stones bilaterally, stricture in the ureteric region, previous stone passage, using alpha-adrenergic receptor blockers, and pregnant women and patients who lost follow up were excluded.
Intervention groups
Group A 8 mg capsule of Silodosin was given for 28 days and once daily and advised for urine collection and discontinuation of the medication upon passage of stone, with the time and date of passage recorded. Group B underwent ESWL
Main outcome variables
Demographic and basekine data, including age, duration of symptoms, BMI, hypertensive status, and diabetes, were recorded. Baseline investigations, including a computed tomography (CT) scan of the kidneys, ureters, and bladder (KUB), were performed to measure the size of the stone. After 1 month of treatment, patients underwent computed tomography scans to detect any residual stones or fragments in the ureter. If stones were not found, the patient was classified as stone-free.

General information

Reason for update
Acronym
SILES: Silodosin vs. ESWL for Lithiasis Evaluation Study
IRCT registration information
IRCT registration number: IRCT20250125064509N1
Registration date: 2025-02-06, 1403/11/18
Registration timing: retrospective

Last update: 2025-02-06, 1403/11/18
Update count: 0
Registration date
2025-02-06, 1403/11/18
Registrant information
Name
Zakir Hussain Rajpar
Name of organization / entity
Liaquat University of Medical and Health Sciences
Country
Pakistan
Phone
+92 300 9370622
Email address
zrajpar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
2023-08-01, 1402/05/10
Actual recruitment end date
2024-06-30, 1403/04/10
Trial completion date
2024-06-30, 1403/04/10
Scientific title
Comparison between Silodosin and Extracorporeal Shockwave Lithotripsy
Public title
Comparison between Silodosin and Extracorporeal Shockwave Lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages of 15-70 years Both gender Stone sizes 5-10mm in the lower ureteric region
Exclusion criteria:
Single functional kidney before treatment Previous ureteric surgery Ureteric stones bilaterally Stricture in the ureteric region Previous stone passage, Using alpha-adrenergic receptor blockers Pregnant women Patients who lost follow up
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 192
Actual sample size reached: 192
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups by lottery method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding maintenance was ensured by using envelopes/slips that indicate only the group allocation without revealing the intervention details, keeping trial participants, data collectors, and outcome assessors blinded; additionally, interventions was designed to appear identical where feasible, such as in color, consistency, or packaging.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Liaquat University of Medical and Health Sciences, Jamshoro, Hyderabad.
Street address
Liaquat University of Medical and Health Sciences
City
Jamshoro, Hyderabad
Postal code
76080
Approval date
2023-02-04, 1401/11/15
Ethics committee reference number
LUMHS/REC/500

Health conditions studied

1

Description of health condition studied
Lower ureteric stone
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stone Clearance Rate
Timepoint
After 1 month of treatment
Method of measurement
computed tomography scans to detect any residual stones or fragments in the ureter

Secondary outcomes

1

Description
occurrence of complications like Pain, Bleeding, Dizziness, Postural hypotension, retrograde ejacualation
Timepoint
1 month after treatment
Method of measurement
Patients complain and and examination

Intervention groups

1

Description
Intervention group: Shock wave lithotripsy
Category
Treatment - Surgery

2

Description
Control group: Sildosin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Liaquat university of medical and health sciences, Jamshoro
Full name of responsible person
Zakir Hussain Rajpar
Street address
Liaquat university of medical and health sciences
City
Jamshoro
Postal code
76080
Phone
+92 300 9370622
Email
zrajpar@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Liaquat University of Medical and Health Sciences
Full name of responsible person
Zakir Hussain Rajpar
Street address
LUMHS
City
Jamshoro
Postal code
76080
Phone
+92 300 9370622
Email
zrajpar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Liaquat University of Medical and Health Sciences
Full name of responsible person
Zakir Hussain Rajpar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
LUMHS
City
Jamshoro
Province
Sindh
Postal code
76080
Phone
+92 300 9370622
Email
zrajpar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Liaquat University of Medical and Health Sciences
Full name of responsible person
Zakir Hussain Rajpar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
LUMHS
City
Jamshoro
Province
Sindh
Postal code
76080
Phone
+92 300 9370622
Email
zrajpar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Liaquat University of Medical and Health Sciences
Full name of responsible person
Zakir Hussain Rajpar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
LUMHS
City
Jamshoro
Province
Sindh
Postal code
76080
Phone
+92 300 9370622
Email
zrajpar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidential data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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