Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000569909
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
Oral Silodosin on Lower Urinary Tract Symptoms Due to Double-J stent: A Prospectively Randomized Study
Scientific title
Oral silodosin on lower urinary tract symptoms due to double-J stent
Secondary ID [1] 262296 0
Nil
Universal Trial Number (UTN)
U1111-1121-8585
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary symptoms assosciated with indwelling double-J ureteral stents 268004 0
Condition category
Condition code
Renal and Urogenital 268133 268133 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
daily oral silodosin 4 mg for 2 weeks in improving symptoms and quality of life in patients with indwelling double-J ureteral stents using specific questionnaire
Intervention code [1] 266688 0
Treatment: Drugs
Comparator / control treatment
daily oral lactose tablet for 2 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 266881 0
ureteral stent symptom questionnaire (USSQ) evaluating the symptoms associated with double-J stents
Timepoint [1] 266881 0
at 2nd week and 4th week
Primary outcome [2] 266892 0
quality of life of International Prostate Symptom Scale (IPSS) evaluating the symptoms associated with double-J stents
Timepoint [2] 266892 0
at 2nd week and 4th week
Secondary outcome [1] 276561 0
Nil
Timepoint [1] 276561 0
Nil

Eligibility
Key inclusion criteria
patients, with insertion of a double-J ureteral stent after ureteroscopic stone removal, were enrolled into the study
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
benign prostatic hyperplasia-related lower urinary symptoms(International Prostate Symptom Score greater greater than 7); a history of interstitial cystitis, chronic cystitis, chronic prostatitis, or stent insertion; and chronic medication with alpha-blockers or analgesics

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
1/11/2010
Actual
1/11/2010
Date of last participant enrolment
Anticipated
30/04/2012
Actual
30/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3610 0
Taiwan, Province Of China
State/province [1] 3610 0

Funding & Sponsors
Funding source category [1] 267176 0
Self funded/Unfunded
Name [1] 267176 0
Chung Jing Wang
Country [1] 267176 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] 266250 0
None
Name [1] 266250 0
Address [1] 266250 0
Country [1] 266250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269171 0
IRB STM
Ethics committee address [1] 269171 0
60058 No 565 2nd Rd Ta-Ya Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Ethics committee country [1] 269171 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269171 0
28/06/2010
Approval date [1] 269171 0
21/07/2010
Ethics approval number [1] 269171 0

Summary
Brief summary
a randomized double-blinded controlled study to evaluate the effect of silodosin in improving symptoms and quality of life in patients with indwelling double-J ureteral stents using specific questionnaire
Trial website
Trial related presentations / publications
not yet
Public notes

Contacts
Principal investigator
Name 32690 0
A/Prof Chung Jing Wang
Address 32690 0
60058 No 565 2nd Ta-Ya Rd, Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 32690 0
Taiwan, Province Of China
Phone 32690 0
886-5-2756000-1013
Fax 32690 0
Email 32690 0
[email protected]
Contact person for public queries
Name 15937 0
A/Prof Chung Jing Wang
Address 15937 0
60058 No 565 2nd Ta-Ya Rd, Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 15937 0
Taiwan, Province Of China
Phone 15937 0
886-5-2756000-1013
Fax 15937 0
886-5-2788535
Email 15937 0
[email protected]
Contact person for scientific queries
Name 6865 0
A/Prof Chung Jing Wang
Address 6865 0
60058 No 565 2nd Ta-Ya Rd, Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 6865 0
Taiwan, Province Of China
Phone 6865 0
886-5-2756000-1013
Fax 6865 0
886-5-2788535
Email 6865 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
No additional documents have been identified.