Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001022055
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
22/11/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Solifenacin to relieve ureteral stent-related symptoms:
A randomized, double-blinded placebo-controlled study
Scientific title
For patients with ureteral stent insertion after ureteroscopic stone manipulations, is Solifenacin effective in relieving ureteral stent-related symptoms?
Secondary ID [1] 252689 0
NA
Universal Trial Number (UTN)
U1111-1117-0490
Trial acronym
SoRUSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ureteral stent-related symptoms after ureteroscopic stone manipulation. 258198 0
Condition category
Condition code
Renal and Urogenital 258375 258375 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Solifenacin 10 mg orally per day for 2 weeks after surgery
Intervention code [1] 257214 0
Treatment: Drugs
Comparator / control treatment
one microcellulose tablet orally per day for 2 weeks after surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 259219 0
Improvement of ureteral stent-related symptoms will be assessed using the ureteral stent symptom questionnaire (USSQ)
Timepoint [1] 259219 0
1, 3 , and 14 days after ureteral stent insertion.
Secondary outcome [1] 265625 0
"Nil"
Timepoint [1] 265625 0
"Nil"

Eligibility
Key inclusion criteria
From 01/10/2010 to 30/10/2011, all patients with unilateral ureteral stones to be treated with ureteroscopy where temporary stenting is indicated will be considered for enrollment in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had significant ureteral trauma, a preexisting ureteral stent, another secondary surgical procedure that would have impacted patient comfort, ie transurethral resection of the prostate or of bladder tumor, or urinary infection or chronic pain history will be excluded from study.

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)
Randomization will be performed in a 1:1 ratio. Patients will be randomized to placebo and study medication using a random number assignment generated by our research pharmacy. Investigators and patients will be blinded to the randomization scheme and investigators will be blinded to the medication until study termination. Each enrolled patient who received a ureteral stent will be given a blister pack containing 14 unmarked tablets. During the stenting period all patients will be allowed to use ultracet 1# tid on demand. Overall dosage will be documented and compared.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2909 0
Taiwan, Province Of China
State/province [1] 2909 0
Taiwan

Funding & Sponsors
Funding source category [1] 257665 0
Hospital
Name [1] 257665 0
Mennonite Christian Hospital, Taiwan
Country [1] 257665 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Mennonite Christian Hospital, Taiwan
Address
No. 44, Min-Chuan Road, Hualien, 970, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 256880 0
None
Name [1] 256880 0
Address [1] 256880 0
Country [1] 256880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259683 0
Mennonite Christian Hospital Institutional Review Board.
Ethics committee address [1] 259683 0
No. 44, Min-Chuan Road, Hualien, 970, Taiwan
Ethics committee country [1] 259683 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 259683 0
02/06/2010
Approval date [1] 259683 0
13/09/2010
Ethics approval number [1] 259683 0
10-06-021-FR

Summary
Brief summary
Ureteral stents have been an important tool in ureteral procedures. However, indwelling ureteral stents produce varying degrees of complications and discomfort. Although manufacturers have responded with novel stent shapes, materials and drug coatings, no ideal stent has been designed to date that significantly improves these complications. Many investigators have attempted to improve stent-related symptoms by using various agents, including oral anticholinergics. However, the roles of these medications in the treatment of ureteral stent-related symptoms remained unclear. We therefore propose to conduct a randomized, placebo-controlled study to evaluate the possible role of the antimuscarinics Solifenacin for improving stent-related symptoms after ureteroscopic procedures.

The study is designed as a prospective, randomized, double blind, placebo- controlled trial. From 01/10/2010 to 30/09/2011, all patients with unilateral ureteral stones or stricture to be treated with ureteroscopy where temporary stenting is indicated will be considered for enrollment in the study. Patients will be randomly assigned in a concealed fashion to 1 of 2 groups. In group 1 (placebo group), patients will receive placebo orally once daily for two weeks. In group 2, patients will receive Solifenacin 10 mg orally once daily for two weeks.

Randomization will be performed in a 1:1 ratio. Investigators and patients will be blinded to the randomization scheme and investigators will be blinded to the medication until study termination. We estimated 100 patients will be enrolled in this study.

Semirigid ureteroscopy will be performed in all patients using a Wolf 6Fr/7.5Fr dual operating channel semirigid ureteroscope to passively dilate the ureteral orifice and address distal ureteral pathology. Intracorporeal lithotripsy will be performed using a 0.8 J 10 Hz holmium laser. All stents will be placed under ureteroscopic guidance.

Ureteral stent-related symptoms will be measured at various time points via telephone interview by using a 10-cm linear visual analogue scale (VAS) for evaluating suprapubic pain and voiding flank pain, and irritative domain of International Prostate Symptom Scale (IPSS), in which 0 represented no pain and 10 represented extreme pain. Patients will be asked to complete the questionnaires on postoperative day 1, day 3, and on the day of stent removal. The median absolute symptom and VAS scores will be compared for each group at each time point.

The primary outcome measure will be the assessment of the difference in ureteral stent symptoms in the treatment group compared with the placebo group. Statistical analysis will be performed with computer software.
Trial website
NA.
Trial related presentations / publications
NA.
Public notes

Contacts
Principal investigator
Name 31644 0
Address 31644 0
Country 31644 0
Phone 31644 0
Fax 31644 0
Email 31644 0
Contact person for public queries
Name 14891 0
HUI-MIN CHUNG
Address 14891 0
NO. 44, Min-Chuan Road, Hualien, 970, Taiwan
Country 14891 0
Taiwan, Province Of China
Phone 14891 0
886-3-8241457
Fax 14891 0
886-3-8241496
Email 14891 0
hchung@jhsph.edu
Contact person for scientific queries
Name 5819 0
HUI-MING CHUNG
Address 5819 0
NO. 44, Min-Chuan Road, Hualien, 970, Taiwan
Country 5819 0
Taiwan, Province Of China
Phone 5819 0
886-3-8241457
Fax 5819 0
886-3-8241496
Email 5819 0
hchung@jhsph.edu

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.