Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000573954
Ethics application status
Approved
Date submitted
2/06/2011
Date registered
3/06/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjunctive Medical Therapy with Oral Silodosin after Shock Wave Lithotripsy of Lower Ureteral Stone: A randomized controlled study
Scientific title
The efficacy of adjunctive medical therapy with daily oral silodosin(4 mg) after Shock Wave Lithotripsy of lower ureteral stone
Secondary ID [1] 262295 0
Nil
Universal Trial Number (UTN)
U1111-1121-8649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower ureteral stone after ESWL 268003 0
Condition category
Condition code
Renal and Urogenital 268132 268132 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily oral 4 mg silodosin for 2 weeks as adjunctive therapy after ESWL of lower ureteral stones
Intervention code [1] 266687 0
Treatment: Drugs
Comparator / control treatment
Daily oral lactose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 266879 0
the expulsion time
Timepoint [1] 266879 0
reported by patients or stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT at 2 weeks
Primary outcome [2] 266880 0
the expulsion rate
Timepoint [2] 266880 0
stone presence and characteristics were diagnosed through x-ray of kidney-ureter-bladder, abdominal ultrasonography, intravenous urography and nonenhenced CT at 2 weeks
Secondary outcome [1] 276557 0
analgesic consumption
Timepoint [1] 276557 0
recorded by patient diaries for 2 weeks
Secondary outcome [2] 276558 0
lower urinary tract symptoms
Timepoint [2] 276558 0
IPSS questionnaire at 2 weeks
Secondary outcome [3] 276559 0
colic episodes
Timepoint [3] 276559 0
recorded by patient diaries for 2 weeks
Secondary outcome [4] 276560 0
adverse effects
Timepoint [4] 276560 0
Dizziness,postural hypotension recorded by patient diaries daily for 2 weeks

Eligibility
Key inclusion criteria
Stones were calculated according to the diameter along the ureteral axis, and the size was between 4mm and 9 mm. All patients underwent ESWL were enrolled in the study after providing informed consent.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
urinary tract infections, high-grade hydronephrosis, diabetes, ulcers, or a history of hypersensitivity to a-blockers, ureteral stricture and pregnant women,history of spontaneous stone expulsion, hypotension, or those found to have systolic blood pressure lower than 110 mmHg

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
31/12/2011
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3609 0
Taiwan, Province Of China
State/province [1] 3609 0

Funding & Sponsors
Funding source category [1] 267175 0
Self funded/Unfunded
Name [1] 267175 0
Chung Jing Wang
Country [1] 267175 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chung Jing Wang
Address
60058 No 565 2nd Ta-Ya Rd Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 266249 0
None
Name [1] 266249 0
Address [1] 266249 0
Country [1] 266249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269170 0
IRB STM
Ethics committee address [1] 269170 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Ethics committee country [1] 269170 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269170 0
24/03/2010
Approval date [1] 269170 0
16/04/2010
Ethics approval number [1] 269170 0

Summary
Brief summary
a prospective study to evaluate the efficacy of oral silodosin 4 mg as adjunctive therapy after ESWL of lower ureteral stones
Trial website
Trial related presentations / publications
not yet
Public notes

Contacts
Principal investigator
Name 32689 0
A/Prof Chung Jing Wang
Address 32689 0
60058 No 565 Sec 2nd Ta-Ya Rd. Chia-Yi city,Taiwan.
St. Martin De Porres Hospital
Country 32689 0
Taiwan, Province Of China
Phone 32689 0
886-5-2756000-1013
Fax 32689 0
Email 32689 0
[email protected]
Contact person for public queries
Name 15936 0
A/Prof Chung Jing Wang
Address 15936 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Country 15936 0
Taiwan, Province Of China
Phone 15936 0
886-5-2756000-1013
Fax 15936 0
886-5-2788535
Email 15936 0
[email protected]
Contact person for scientific queries
Name 6864 0
A/Prof Chung Jing Wang
Address 6864 0
60058 No 565 2nd Ta-Ya Rd Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Country 6864 0
Taiwan, Province Of China
Phone 6864 0
886-5-2756000-1013
Fax 6864 0
886-5-2788535
Email 6864 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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