Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000987369
Ethics application status
Approved
Date submitted
4/07/2017
Date registered
10/07/2017
Date last updated
4/12/2023
Date data sharing statement initially provided
4/03/2022
Date results information initially provided
4/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
STent EvaluatioN Trial (STENT) - A Multicentre Double Blinded Randomized Controlled Trial Comparing the Bard Inlay Optima Stent with the Cook Universa Soft Ureteral Stents Using The Validated Ureteric Stent Symptom Questionnaire
Scientific title
A Multicentre Double Blinded Randomized Controlled Trial Comparing the Bard Inlay Optima Stent with the Cook Universa Soft Ureteral Stents Using The Validated Ureteric Stent Symptom Questionnaire
Secondary ID [1] 292346 0
Nil Known
Universal Trial Number (UTN)
U1111-1198-7288
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper urinary tract calculi 303895 0
Condition category
Condition code
Surgery 303262 303262 0 0
Other surgery
Renal and Urogenital 303278 303278 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is comparing the Bard Inlay Optima and Cook Universa Soft Ureteral Stents when used for stent insertion for upper urinary tract calculi or large stones before lithotripsy or after ureteroscopy at the Townsville and Toowomba Hospital.

Materials: The materials being used will be first and foremost the two aforementioned stents – the Bard Inlay Optima and Cook Universa Soft Ureteral Stents. Both will be inserted as part of the clinical trial by urological registrars or consultant surgeons at the Townsville and Toowomba Hospital. Their post operative stent symptoms will be measured through two methods. First, the Ureteral Stent Symptoms Questionnaire (USSQ) – a validated questionnaire produced by the Bristol Urological Institute to measure post-operative stent related symptoms. ]

Procedures: Following patient consenting for the procedure, patient’s will have the stent they are randomized to (either Bard Inlay Optima or Cook Universa Soft), inserted by the urologist registrar or consultant as stated above. Intra-operatively, multi-length double J stents of either the Bard Inlay Optima (4.7 French) and Cook Universa Soft (5 french) variety will be inserted. Post operatively, patients will be provided with appropriate medications for stent pain if desired.

Patients will be then receive a phone call from the Principal Investigator (PI) at 1 and 3 weeks after insertion and surveyed as per the USSQ. We would note that throughout this the PI conducting the survey will be blinded to which stent was inserted in the patient. All data will be recorded in a relevant data collection tool in which data pertaining to the date of procedure, patient characteristics, USSQ score and post operative opiod use for SRS. Early stent removal will be defined as having the stent removed prior to 3 weeks.

Who: The intervention will be delivered by a recognized urology registrar or consultant urologist at the Townsville or Toowoomba Hospital. The survey will be conducted by the Principal Investigator, a doctor with experience in urology.

Mode of Delivery: The surveys above will be delivered via telephone surveys delivered individually to each patient with the stent inserted.

Number of times: The intervention (the stenting) will only be delivered once however patients will be followed up at two points – 1 week and 3 weeks post operatively.
Location: The intervention will occur at the Townsville, Toowoomba and Redcliffe Hospital

Intervention Adherence or Fidelity: Patients will be followed up if they have early stent removal and this will be documented accordingly in the data collection tool. A data monitoring board will be set up for the study to ensure randomization and protocol is being carried out as appropriate.
Intervention code [1] 298524 0
Treatment: Devices
Intervention code [2] 323029 0
Treatment: Surgery
Comparator / control treatment
No control group is possible however the comparator will be the Cook Universa Soft.
Control group
Active

Outcomes
Primary outcome [1] 302634 0
USSQ Urinary Score
Timepoint [1] 302634 0
At Week 1 and 3 post stent insertion
Primary outcome [2] 302685 0
USSQ Pain Score
Timepoint [2] 302685 0
At Week 1 and 3 post stent insertion
Primary outcome [3] 302686 0
USSQ General Health Score
Timepoint [3] 302686 0
At Week 1 and 3 post stent insertion
Secondary outcome [1] 336579 0
Number of participants which had early removal of stents. This will be defined as removal of stents prior to three weeks.
Timepoint [1] 336579 0
Anytime within 3 weeks post stent insertion
Secondary outcome [2] 336581 0
The presence or absence of needing opiod use post operatively for stent related symptoms.
Timepoint [2] 336581 0
Anytime within 3 weeks post stent insertion.
Secondary outcome [3] 336747 0
USSQ Sexual Matters Score (note is meant to be primary outcome)
Timepoint [3] 336747 0
1 week post stent insertion

Eligibility
Key inclusion criteria
Setting and Target Participants: All consenting patients receiving stent insertion for upper urinary tract calculi, large stones before lithotripsy or after ureteroscopy or Pelvo-Ureterojunction Obstruction at the Townsville and Towoomba Hospital between the 1st of August 2017 to the 1st of August 2019.

Inclusion criteria
• Patients undergoing unilateral retrograde ureteral stent placement
• Age – over 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Untreated urinary tract infections
• Undergoing additional transurethral procedures or bilateral calculi
• All patients with obstructive uropathy secondary to malignancy
• Anatomical deformities of the urinary tract such as Duplex or Complete Duplex Ureters
• Pelvic radiation therapy
• Current bladder cancer
• Long term indwelling ureteric stents
• Indwelling catheter (IDC) or Suprapubic Catheter (SPC) dependent
• Performing clean intermittent self-catheterisation
• Ureteric stent present in last 31 days or if the patient has been previously recruited for the study
• Post-operative sepsis
• Patients who do not speak English – USSQ version used has been only validated in English
• Patient’s with cognitive impairments or intellectual disabilities preventing them from comprehending or answering the USSQ
• Pregnant women
• Patients with history of:
- Chronic pain
- Bladder or prostate surgeries including:
o Radical Prostatectomy
o Partial cystectomy
o Diveritculectomy
o Ureter reimplant
o Other significant Bladder Surgeries
- Neurogenic bladder
- Chronic alpha-blocker medication, opioid analgesia or anticholinergics
- Spinal cord injury

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)
Patients will first be divided up into 34 groups of 4 and 2 groups of 2 (17 groups of 4 per stent, 2 groups of 2 per stent, 70 patients per stent).

Following this, 1 set of 36 unique numbers will be generated using the “Research Randomizer” (Version 4.0) software. Numbers to be assigned will range from 1 to 36 with each number in the set to remain unique. An assigned individual independent from the study to be steward of randomization will generate this list of numbers upon initiation of the study. From that list of numbers all odd numbers will be converted into “As” and all even numbers converted into “Bs”.

The randomization steward will then have this list of 16As and 16Bs assigned in the order they were generated to each group into a designated table document. For example, if the order generated was A,A,B,A, etc. the resultant table would read “Group 1 – A, Group 2 – A, Group 3 – B, etc., Group 4 - A”. The randomization steward will then decide at the beginning of the study A or B represents Bard or Cook stent groups. All this will be documented at the beginning of the “Stent Study Book” in the space provided.

These pre-assigned stent groups will be documented at the start of the book in order to ensure that theatre staff will collect the correct stent for the procedure if patients consent for the study. It will be made clear from the outset of the study to all theatre staff who collect the stents for the procedure that all investigators associated with the data collection and questionnaire process above will not be privy to this knowledge.

Re-matching patient serial numbers and the relevant data collected during the data collection process to which type of stent they had inserted will only be revealed to any investigators associated with data collection upon completion of the data collection process described above. In doing so, both patient and investigators will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will first be divided up into 34 groups of 4 and 2 groups of 2 (17 groups of 4 per stent, 2 groups of 2 per stent, 70 patients per stent).

Following this, 1 set of 36 unique numbers will be generated using the “Research Randomizer” (Version 4.0) software. Numbers to be assigned will range from 1 to 36 with each number in the set to remain unique. An assigned individual independent from the study to be steward of randomization will generate this list of numbers upon initiation of the study. From that list of numbers all odd numbers will be converted into “As” and all even numbers converted into “Bs”.

The randomization steward will then have this list of 16As and 16Bs assigned in the order they were generated to each group into a designated table document. For example, if the order generated was A,A,B,A, etc. the resultant table would read “Group 1 – A, Group 2 – A, Group 3 – B, etc., Group 4 - A”. The randomization steward will then decide at the beginning of the study A or B represents Bard or Cook stent groups. All this will be documented at the beginning of the “Stent Study Book” in the space provided.

These pre-assigned stent groups will be documented at the start of the book in order to ensure that theatre staff will collect the correct stent for the procedure if patients consent for the study. It will be made clear from the outset of the study to all theatre staff who collect the stents for the procedure that all investigators associated with the data collection and questionnaire process above will not be privy to this knowledge.

Re-matching patient serial numbers and the relevant data collected during the data collection process to which type of stent they had inserted will only be revealed to any investigators associated with data collection upon completion of the data collection process described above. In doing so, both patient and investigators will be blinded.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Data Monitoring
Data will be monitored by an independent committee organized by an assigned associate investigator (Doctor Rajan Narula, Consultant Urologist, Director of Urology at the Townsville Hospital). Regular meetings will be conducted to ensure that the study is following its protocol. The study will be ceased if at any point new information or studies are published suggesting that either stent being analysed has a superior stent related symptoms profile compared to the other.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Tests of normality will be done to ascertain parametric and non-parametric methods for statistical analysis. Where appropriate, data will be presented as mean, median and interquartile range.

Correlation and regression tests will be done to determine association between continuous variables. Chi square test will be used to determine association between categorical variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2017
Actual
6/11/2017
Date of last participant enrolment
Anticipated
1/08/2019
Actual
9/05/2021
Date of last data collection
Anticipated
11/10/2019
Actual
30/05/2021
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8475 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 12159 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 21878 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 36943 0
4020 - Redcliffe
Recruitment postcode(s) [2] 24328 0
4350 - Toowoomba
Recruitment postcode(s) [3] 16559 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 300921 0
Self funded/Unfunded
Name [1] 300921 0
Alexander Ngoo
Country [1] 300921 0
Australia
Primary sponsor type
Individual
Name
Doctor Alexander Ngoo
Address
100 Angus Smith Dr, Douglas QLD 4814
The Townsville Hospital
Country
Australia
Secondary sponsor category [1] 295905 0
Individual
Name [1] 295905 0
Dr Phillipe Wolanski
Address [1] 295905 0
100 Angus Smith Dr, Douglas QLD 4814
The Townsville Hospital
Country [1] 295905 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298114 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298114 0
PO Box 670
Townsville Qld 4810
Ethics committee country [1] 298114 0
Australia
Date submitted for ethics approval [1] 298114 0
29/06/2017
Approval date [1] 298114 0
22/08/2017
Ethics approval number [1] 298114 0

Summary
Brief summary
Ureteral stents can often cause significant post-stent morbidity and discomfort. There are many different brands of stents currently available but there is no evidence that there is any difference between them in terms of stent related symptoms. This study aims to compare the Cook Universa Soft and Bard Inlay Optima Stents post-op stent related symptoms (SRS) in relation to the validated Ureteral Stent Symptom Questionnaire. This comparison will be through a randomized double-blinded trial of the two different brands of stents.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A
Attachments [1] 3164 3164 0 0
/AnzctrAttachments/373245-Stent_Study_Protocol_V5_-_Multicentre_Clean.docx (Protocol)
Attachments [2] 3165 3165 0 0
/AnzctrAttachments/373245-PICF_Consent_Form_Toowoomba V1.docx (Participant information/consent)
Attachments [3] 3166 3166 0 0
/AnzctrAttachments/373245-PICF_Consent_Form_V4_FINAL Clean.docx (Participant information/consent)

Contacts
Principal investigator
Name 76038 0
Dr Alexander Ngoo
Address 76038 0
PO Box 670
100 Angus Smith Drive, Douglas Queensland 4814
The Townsville Hospital
Country 76038 0
Australia
Phone 76038 0
+61744331801
Fax 76038 0
Email 76038 0
AlexanderGa-Onn.Ngoo@health.qld.gov.au
Contact person for public queries
Name 76039 0
Dr Alexander Ngoo
Address 76039 0
PO Box 670
100 Angus Smith Drive, Douglas Queensland 4814
The Townsville Hospital
Country 76039 0
Australia
Phone 76039 0
+61744331801
Fax 76039 0
Email 76039 0
AlexanderGa-Onn.Ngoo@health.qld.gov.au
Contact person for scientific queries
Name 76040 0
Dr Alexander Ngoo
Address 76040 0
PO Box 670
100 Angus Smith Drive, Douglas Queensland 4814
The Townsville Hospital
Country 76040 0
Australia
Phone 76040 0
+61744331801
Fax 76040 0
Email 76040 0
AlexanderGa-Onn.Ngoo@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15298Study protocol    373245-(Uploaded-21-02-2022-13-46-22)-Study-related document.docx
15299Informed consent form    373245-(Uploaded-21-02-2022-13-46-41)-Study-related document.docx
15300Ethical approval    373245-(Uploaded-21-02-2022-13-47-42)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Accepted 26 July 2023, Available online 10 August ... [More Details]
Plain language summaryNo The Bard Inlay Optima’s anti-inflammatory pHreecoa... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Prospective, Randomized Controlled Multicenter Trial Comparing the Bard Inlay Optima and the Cook Universa Soft Stent.2023https://dx.doi.org/10.1016/j.urology.2023.07.030
N.B. These documents automatically identified may not have been verified by the study sponsor.