ANZCTR - Registration

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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]

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.

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Drugs

Comparator / control treatment

one microcellulose tablet orally per day for 2 weeks after surgery.

Control group

Placebo

Outcomes

Primary outcome [1]

Improvement of ureteral stent-related symptoms will be assessed using the ureteral stent symptom questionnaire (USSQ)

Timepoint [1]

1, 3 , and 14 days after ureteral stent insertion.

Secondary outcome [1]

"Nil"

Timepoint [1]

"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?

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]

Taiwan, Province Of China

State/province [1]

Taiwan

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mennonite Christian Hospital, Taiwan

Address [1]

No. 44, Min-Chuan Road, Hualien, 970, Taiwan

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mennonite Christian Hospital Institutional Review Board.

Ethics committee address [1]

No. 44, Min-Chuan Road, Hualien, 970, Taiwan

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

02/06/2010

Approval date [1]

13/09/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

HUI-MIN CHUNG

Address

NO. 44, Min-Chuan Road, Hualien, 970, Taiwan

Country

Taiwan, Province Of China

Phone

886-3-8241457

Fax

886-3-8241496

hchung@jhsph.edu

Contact person for scientific queries

Name

HUI-MING CHUNG

Address

NO. 44, Min-Chuan Road, Hualien, 970, Taiwan

Country

Taiwan, Province Of China

Phone

886-3-8241457

Fax

886-3-8241496

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.

Trial Review

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