Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy: A Prospective Feasibility Study
Phase: NA
Conditions: Ureter Calculi
Sponsor: Austin Health

 
 
 
 
 
PROTOCOL  
Observing the migration 
rates and patient-
reported stent-related 
outcomes of Single J 
Ureteric Stents following 
Ureteroscopy 
Protocol Number (Mandatory field): 
Version: #3.0 
Date: 08/09/2025 
 
Author/s: 
Joseph Ischia, Anthony Ta, Varun Buhariwalla 
 
Sponsor/s: 
Nil 

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CONFIDENTIAL 
 
This document is confidential and the property of Austin Health. No part of it may be 
transmitted, reproduced, published, or used without prior written authorization from the 
institution. 
 
Statement of Compliance 
 
This document is a protocol for a research project. This study will be conducted in 
compliance with all stipulation of this protocol, the conditions of the ethics committee 
approval, the NHMRC National Statement on ethical Conduct in Human Research (2007) 
and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95). 

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TABLE OF CONTENTS 
CONTENTS 
Table of Contents .................................................................................................................. 3 
Study Synopsis …….……………………………………………………………………………….. 5 
1. 
Glossary of Abbreviations & Terms ........................................................................ 5 
2. 
Study Sites ................................................................................................................ 6 
2.1 
Study Location/s .................................................................................................. 6 
3. 
Introduction/Background Information .................................................................... 7 
3.1 
Lay Summary ...................................................................................................... 7 
3.2 
Introduction ......................................................................................................... 8 
3.3 
Background information ....................................................................................... 8 
4. 
Study Objectives ...................................................................................................... 9 
4.1 
Hypothesis .......................................................................................................... 9 
4.2 
Study Aims .......................................................................................................... 9 
4.3 
Outcome Measures ........................................................................................... 10 
5. 
Study Design .............................................................................................................. 10 
5.1 
Study Type & Design & Schedule ...................................................................... 10 
5.2 
Standard Care and Additional to Standard Care Procedures ............................. 11 
5.3 
Randomisation .................................................................................................. 12 
5.4 
Study methodology ............................................................................................... 12 
6. 
Study Population .................................................................................................... 14 
6.1 
Recruitment Procedure ...................................................................................... 14 
6.2 
Inclusion Criteria ................................................................................................ 16 
6.3 
Exclusion Criteria .............................................................................................. 16 
6.4 
Consent ............................................................................................................. 17 
7. 
Participant Safety and Withdrawal ............................................................................ 19 
7.1 
Risk Management and Safety ............................................................................ 19 

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7.2 
Handling of Withdrawals .................................................................................... 20 
7.3 
Replacements ................................................................................................... 21 
8. 
Statistical Methods .................................................................................................... 21 
8.1 
Sample Size Estimation & Justification .............................................................. 21 
8.2 
Power Calculations ............................................................................................ 22 
8.3 
Statistical Methods To Be Undertaken ............................................................... 22 
9. 
Storage of Blood and Tissue Samples ..................................................................... 23 
9.1 
Details of where samples will be stored, and the type of consent for future use of 
samples ........................................................................................................................... 23 
10. 
Data Security & Handling ....................................................................................... 23 
10.1 Details of where records will be kept & How long will they be stored ................. 23 
10.2 Confidentiality and Security ............................................................................... 23 
10.3 Ancillary data ..................................................................................................... 23 
11. 
References .............................................................................................................. 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY SYNOPSIS 
(please provide a brief information) 
 
 
 
Title: 
Observing the migration rates and patient-reported stent-
related outcomes of Single J Ureteric Stents following 
Ureteroscopy 
Short Title: 
Single J Ureteric Stents following Ureteroscopy 
Design: 
Interventional, non-randomised single-centre prospective 
cohort study 
Study Centres: 
Austin Health 
Hospital: 
Austin Hospital; Heidelberg Repatriation Hospital 
Study Question: 
Is a Single-J ureteric stent with no distal loop in the bladder a 
valid, safe and beneficial alternative to Double-J stents 
following Ureteroscopy? 
Study Objectives: 
Understand how well SJS are tolerated by patients in 
comparison to standard DJS and if they are safe in their 
rates of migration. 
Primary Objectives: 
Measure stent migration rates in patients with Single-J 
Ureteric Stents post Urological Surgeries 
Secondary Objectives 
1. Patient-reported postoperative stent-related symptom 
scores on a validated Questionnaire (USDT) 
2. Stent-related complications (infection, encrustation, 
hematuria) 
Inclusion Criteria: 
• 
Age ≥18 years. 
• 
Undergoing elective URS or Pyeloscopy and stent 
exchange for ureteric stone disease. 
• 
Already pre-stented with a Double-J ureteric stent prior 
to URS. 
• 
Able and willing to provide informed consent. 
• 
Sufficient English proficiency to complete symptom 
questionnaires (USDT). 
Exclusion Criteria:  
• 
Single kidney or bilateral ureteric disease. 
• 
History of ureteric strictures or prior ureteric 
reconstruction. 
• 
Pregnancy or breastfeeding. 
• 
Active urinary tract infection at time of URS. 
• 
Immunocompromised state (e.g., ongoing 
chemotherapy, high-dose steroids). 
• 
Any contraindication to ureteric stenting or flexible 
cystoscopy. 

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• 
Patients unwilling or unable to comply with follow-up 
procedures. 
• 
Complex surgical case 
o Very large ureteric stone (>10mm), impacted 
stone, stone in intramural ureter, difficult 
stent, significant bleeding after stenting 
Number of Planned Subjects: 
40 
Investigational product: 
Modified Bander Ureteral Diversion Stent 
Safety considerations: 
Possible increased risk of stent migration due to absence of 
distal loop 
Statistical Methods: 
• 
Comparison of USDT scores with DJS and SJS within 
participants using the paired t-test for normally 
distributed data. 
• 
If normality assumptions are violated, the Wilcoxon 
signed-rank test will be applied. 
• 
Descriptive Statistics for demographics 
Subgroups: 
 
PhD or Masters student using 
data towards their degree: 
☐ Yes, please contact the Office for Research to discuss whether 
an agreement is needed   
☒ No 
 
1. GLOSSARY OF ABBREVIATIONS & TERMS 
 
Abbreviation 
Description (using lay language) 
SJS 
Single-J Stents 
DJS 
Double-J Stents 
URS 
Ureteroscopy 
USDT 
Ureteric Stent Discomfort Test 
 
2. STUDY SITES 
 
a. STUDY LOCATION/S  
 

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Site 
Address 
Contact 
Person 
Phone 
Email 
Austin 
Hospital 
145 Studley 
Rd, 
Heidelberg 
VIC 3084 
Varun 
Buhariwalla 
0424628495 
Varun.buhariwalla@austin.org.au 
Heidelberg 
Repatriation 
Hospital 
300 
Waterdale 
Rd, 
Ivanhoe 
VIC 3079 
Varun 
Buhariwalla 
0424628495 
Varun.buhariwalla@austin.org.au 
 
3. INTRODUCTION/BACKGROUND INFORMATION 
a. LAY SUMMARY 
This study aims to investigate a new approach to ureteric stenting following ureteroscopic 
stone surgery. Normally, after such procedures, patients have a Double-J (DJS) stent 
inserted, which loops at both ends inside the body. These stents are effective but often 
cause discomfort, bladder irritation, and other urinary symptoms. 
 
In this study, we aim to modify a standard Bander Ureteral stent, normally used in 
Cystectomy surgeries, by shortening its straight lower end to create a Single-J stent (SJS). 
This stent will have only the top loop (in the kidney), and a straight end that sits in the 
bladder. The goal is to reduce discomfort while maintaining safety and effectiveness. 
 
Participants in this study will already have a DJS in place from a prior procedure and will be 
undergoing planned ureteroscopy (URS) to remove their ureteric stone. At the end of that 
procedure, the modified SJS will be inserted. Participants will complete a short symptom 
questionnaire (USDT) both while the DJS is in and again after having the SJS, allowing a 
direct comparison. A flexible cystoscopy will be performed at stent removal to check for 
movement of the stent. 
 
Participation involves minimal extra time, 
as all procedures would be happening as 
part of routine care. The only added steps 
are completing the symptom questionnaire 
and reviewing stent position at removal. 
Safety will be monitored closely throughout 
the study. Participation is entirely 
voluntary. 
 
Figure. Cook Medical Bander Ureteral 
Diversion Stent Set. Standard of care in 
Cystectomy Ileal Conduit Surgery. 
https://www.cookmedical.com/products/uro_diversion_webds/   

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b. INTRODUCTION 
Ureteric stenting is a cornerstone of postoperative management following ureteroscopy 
(URS) for ureteric stones. Although the Double-J (DJS) stent is the most commonly used 
device due to its anti-migration design, it is associated with significant stent-related 
discomfort and lower urinary tract symptoms (LUTS). A novel approach that modifies the 
DJS to create a Single-J stent (SJS) by removing its distal loop may offer symptom relief 
while maintaining clinical safety and efficacy. 
 
This study is designed to investigate whether a modified SJS—created from an existing 
commercial DJS—offers a viable alternative in patients undergoing URS with pre-stenting. 
We hypothesize that the SJS will reduce urinary symptoms and discomfort while retaining 
sufficient positional stability. 
 
This prospective interventional cohort study is, to our knowledge, the first Australian 
feasibility study evaluating post-URS outcomes with a modified SJS in a controlled, head-to-
head comparison with prior DJS use in the same patients. 
c. BACKGROUND INFORMATION 
 
Stent-related symptoms are a common issue in endourology, often contributing to decreased 
patient satisfaction, increased healthcare use, and poorer quality of life. In recent years, 
interest has grown in reducing these adverse outcomes by innovating stent design. The 
majority of current studies on SJS devices are limited to case series, technical reports, or 
comparisons with DJS in non-post-URS contexts. 
 
Literature from 10 key journal articles reveals the following: 
• 
Migration is a major concern with SJS, but proper positioning and technique can 
mitigate this risk (Yang et al., Lai et al.). 
• 
Several case series demonstrate successful SJS use without flexible cystoscopy or 
nephrostomy intervention (Yang et al., Koike et al.). 
• 
The FaST trial (Bach et al.) and Ooms et al. study highlight patient-reported benefits 
with shorter stents or external catheters. 
• 
Quality of life is significantly impacted by stent design; symptom questionnaires like 
USSQ and USDT are commonly used for assessment. 
• 
Data on SJS migration show low rates of dislodgement in controlled settings with 
regular follow-up. 
 
Despite some promising evidence, the literature lacks a structured, prospective head-to-
head evaluation of modified SJS compared to DJS in the same patients—especially using 
validated symptom scores. 
 
This study aims to address that gap by: 
• 
Standardizing the SJS modification from a known commercial stent 
• 
Including only patients who previously had a DJS to allow for intra-patient 
comparison 

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• 
Using USDT, a validated patient symptom questionnaire, to assess subjective 
outcomes 
• 
Confirming migration rates by cystoscopic evaluation 
 
The study aligns with clinical interest in improving patient experience post-URS while 
ensuring that no compromise occurs in clinical outcomes such as migration or infection 
rates. 
 
4. STUDY OBJECTIVES 
a. HYPOTHESIS  
We hypothesise that: 
• 
A modified Single-J stent (SJS), created by removing the distal loop off a standard 
fixed or multi-length Double-J stent, is feasible and safe for use following 
ureteroscopy (URS) in pre-stented patients. 
• 
The SJS will result in significantly reduced stent-related symptoms compared to the 
standard DJS, as measured by the Ureteral Stent Discomfort Test (USDT). 
• 
The SJS will demonstrate minimal risk of migration, with a clinically acceptable 
migration rate (defined as ≤5%). 
• 
The SJS will be associated with no increase in adverse events relative to DJS, based 
on clinical review and literature precedent. 
 
b. STUDY AIMS 
 
Primary Aim: 
• 
To evaluate the feasibility, safety, and symptom burden of a modified Single-J stent 
in patients undergoing URS for ureteric stones. 
Secondary Aims: 
• 
To assess and compare stent-related discomfort using USDT before and after SJS 
insertion (compared within the same patients who had prior DJS). 
• 
To determine the migration rate of the SJS based on cystoscopic evaluation at time 
of stent removal. 
• 
To document any procedure-related or stent-related complications (e.g., infection, 
haematuria, emergency re-intervention). 
• 
To evaluate patient satisfaction with the SJS and willingness to undergo similar 
management in the future. 
• 
To collect data on operative metrics, including time to insert the SJS and any 
intraoperative handling issues. 

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c. OUTCOME MEASURES 
 
Primary Outcome Measure: 
• 
SJS migration, assessed by flexible cystoscopy at removal and categorised by: 
o 
Tip within bladder 
o 
At ureteric orifice (UO) 
o 
In urethra 
o 
Not visualised 
 
Secondary Outcome Measures: 
• 
Change in USDT score before (with DJS in situ) and after (with SJS in situ) URS, 
assessed within-subject using a validated tool. 
• 
Incidence of adverse events, including: 
o 
Symptomatic urinary tract infections (UTIs) 
o 
Haematuria requiring medical attention 
o 
Emergency department presentation or hospital readmission 
o 
Need for early SJS removal or re-intervention 
• 
Ease of stent insertion and time taken, documented by operating surgeon. 
 
5. STUDY DESIGN 
a. STUDY TYPE & DESIGN & SCHEDULE 
 
This is a prospective, single-arm, interventional feasibility study conducted at a single 
tertiary care urology centre. 
• 
Study Type: Interventional, non-randomised 
• 
Design: Prospective cohort with intra-patient comparison (before-and-after) 
• 
Control Mechanism: Within-subject comparison of symptoms (DJS vs SJS) 
• 
Sample Size: Target recruitment of 40 participants maximum 
• 
Study Duration per Participant: Approximately 3–4 weeks, depending on timing of 
URS and stent removal 
• 
Total Study Duration: Estimated 6 months including enrolment and follow-up 
 
Assessment / Procedure 
Screening Visit (Before 
or at enrolment) 
URS Visit 
(Day 0) 
Stent Removal 
Visit (Day 14 ± 2) 
Eligibility assessment 
  
Informed consent 
  
  (if not 
done earlier) 
 

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Demographic and medical 
history collection 
  
 
 
Baseline DJS symptom 
assessment (USDT) 
  
  (if not 
done earlier) 
URS procedure and stone 
treatment 
  
Removal of pre-existing DJS 
  
Insertion of modified Single-
J stent 
  
SJS symptom assessment 
(USDT) 
  
Stent migration assessment 
(cystoscopic exam) 
  
Adverse event monitoring 
 
  
  
Final clinical review 
  
 
 
b. STANDARD CARE AND ADDITIONAL TO STANDARD CARE 
PROCEDURES  
 
Participants will receive all aspects of routine care for ureteric stone management, including 
URS and post-operative stenting. The only investigational component is the use of a 
modified SJS, and the repeat use of the USDT symptom questionnaire. 
 
Table 1: Standard Care Procedures 
Visit/Timepoint 
Standard Care Procedures 
At emergency/ elective stent 
placement 
Insertion of standard DJS 
Pre-operative assessment 
Routine pre-URS evaluation, bloods, imaging, consent 
URS and laser lithotripsy 
Standard endoscopic treatment with stone 
fragmentation and removal 
Post-operative care 
Monitoring, analgesia, discharge planning 
Stent removal (2 weeks post-op) 
Cystoscopic removal of stent under local anaesthesia or 

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sedation 
 
Table 2: Additional to Standard Care (Study-Specific) Procedures 
Visit/Timepoint 
Additional/Research Procedures 
Pre-URS (with DJS in situ) 
Administer USDT questionnaire. Patient’s pre-op CT scan will 
be reviewed to measure ureteral length 
At URS (intra-op) 
Replace DJS with modified SJS (distal loop of DJS trimmed) 
Post-URS (day of 
discharge or review) 
Record intra-op findings and SJS placement data 
Stent removal (at 2-week 
cystoscopy) 
Administer USDT questionnaire, assess stent migration 
location, collect feedback 
c. RANDOMISATION 
 
As this is a non-randomised, single-arm feasibility study, no randomisation procedures 
will be used. All enrolled participants will receive the same intervention. The study design 
allows for each participant to serve as their own control by comparing their symptoms 
between two different time points (with DJS vs with SJS). 
 
d. STUDY METHODOLOGY  
Recruitment: 
• 
Patients presenting to urology outpatient clinics or emergency departments who are 
already pre-stented with a DJS for a unilateral ureteric stone will be screened. 
• 
Suitable candidates will be provided with verbal and written study information, and 
informed consent will be obtained. 
 
Intervention: 
• 
At the time of their scheduled URS and laser lithotripsy, the standard DJS will be 
removed. 
• 
A modified SJS will be fashioned from a Bander ureteral stent by shortening it to 28 
cm from the end of the proximal curve. 
• 
A 2-0 monofilament non-absorbable prolene suture will be anchored to the distal end 
of the SJS. Measured to 7cm 
• 
The modified SJS will be placed in standard fashion under fluoroscopic guidance. 
 
Symptom Assessment: 
• 
All participants will complete the USDT while the DJS is in situ (prior to URS). 
• 
The same questionnaire will be completed again while the SJS is in place (2 weeks 
post-URS at time of stent removal). 

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Migration Assessment: 
• 
At time of SJS removal via flexible cystoscopy, migration status will be categorised 
as follows: 
o 
SJS tip freely floating in bladder 
o 
SJS tip at ureteric orifice 
o 
SJS tip in urethra 
o 
SJS tip not visualised 
Adverse Events Monitoring: 
• 
Participants will be asked about emergency presentations, symptoms of infection, 
haematuria, or intolerable discomfort during the stent period. 
• 
All adverse events (AEs) related to the modified SJS will be recorded and monitored. 
Any serious adverse events (SAEs) will be reported to the Human Research Ethics 
Committee (HREC) in accordance with local governance procedures. 
• 
An Adverse Event (AE) is any untoward medical occurrence in a participant. A Serious 
Adverse Event (SAE) is any event that results in death, is life-threatening, requires 
hospitalisation, or results in significant disability. 
• 
All SAEs will be reported to the Principal Investigator within 24 hours of site 
awareness. 
• 
The PI will report SAEs to the Austin Health HREC and Research Governance Office 
within required timelines (usually within 72 hours) as per institutional and NHMRC 
policy. 
• 
AEs will be recorded in the participant’s medical record and the study CRF/REDCap 
database. 
• 
Participants experiencing harm will receive appropriate medical care, and any study-
related events will be documented and reviewed in safety monitoring. 
• 
 
Data Collection: 
• 
Data on demographics, stone characteristics, intraoperative findings, and stent-
related complications will be collected and stored securely in a REDCap database. 
• 
All clinical data, USDT scores, and cystoscopic assessments will be recorded in 
secure electronic case report forms (eCRFs). Study data will be stored in accordance 
with Good Clinical Practice (GCP) and institutional data governance policies. All 
identifying patient information will be de-identified in analysis datasets. 

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6. STUDY POPULATION 
a. RECRUITMENT PROCEDURE 

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Pre-Screening Identification of Eligible Participants 
• 
Source: Patients will be identified from the elective surgical booking list for 
ureteroscopy (URS), laser lithotripsy, and ureteric stent exchange procedures. 
• 
Referrals are received through standard hospital pathways, including outpatient 
urology clinics, emergency department follow-up, and internal referrals by urology 
registrars/consultants. 
• 
Clinical screening for eligibility will be performed by the principal investigator or a 
designated urology registrar by reviewing medical records and operation bookings. 
Recruitment Approach 
• 
Once a patient is confirmed to be undergoing elective URS with pre-existing Double-
J stent in place: 
o 
Initial contact will be made via telephone or in-person in clinic at least several 
days prior to the scheduled URS. 
o 
Patients will be informed that they are eligible for a research study evaluating 
a modified ureteric stent (Single-J stent or SJS). 
o 
A Participant Information Sheet and Consent Form (PICF) will be emailed 
or posted, or provided in person, depending on timing and logistics. 
• 
On the day of surgery (prior to anaesthesia): 
o 
The research team will be available to answer any additional questions. 
o 
Informed consent will be formally obtained before any study-related 
procedures. 
Eligibility Confirmation 
• 
Final confirmation of eligibility will occur on the day of surgery following: 
o 
Verification of pre-stented status 
o 
Absence of active infection or anatomical contraindications to SJS 
o 
Reaffirmation of voluntary participation and comprehension of the study 
Recruitment Duration 
• 
Recruitment is expected to occur over a 6-month period, aiming to enrol 40 
patients total. 
Equity and Accessibility 
• 
All eligible patients will be approached regardless of gender, race, or socioeconomic 
background. 
• 
Consideration will be given to: 

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o 
Providing interpreters for patients with limited English (if feasible) 
o 
Ensuring all patients are given equal opportunity to participate and adequate 
time to consider involvement 
Reimbursement 
• 
No financial incentives will be offered. Participation is voluntary and all stent 
procedures are part of standard care, aside from the investigational stent 
modification. 
Target Population: 
• 
Adults aged ≥18 years undergoing elective ureteroscopy (URS) and stent exchange 
for ureteric stone management. 
• 
All participants will have a pre-existing Double-J stent (DJS) in situ prior to URS. 
Rationale: 
• 
Pre-stented patients can provide direct symptom comparison between DJS and the 
investigational Single-J stent (SJS). 
• 
This cohort closely reflects standard clinical practice, enhancing real-world relevance. 
 
b.  INCLUSION CRITERIA  
 
Inclusion Criteria: 
• 
Age ≥18 years. 
• 
Undergoing elective URS and stent exchange for ureteric stone disease. 
• 
Already pre-stented with a Double-J ureteric stent prior to URS. 
• 
Able and willing to provide informed consent. 
• 
Sufficient English proficiency to complete symptom questionnaires (USDT). 
 
c. EXCLUSION CRITERIA  
 
Exclusion Criteria: 
• 
Single kidney or bilateral ureteric disease. 
• 
History of ureteric strictures or prior ureteric reconstruction. 
• 
Pregnancy or breastfeeding. 

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• 
Active urinary tract infection at time of URS. 
• 
Immunocompromised state (e.g., ongoing chemotherapy, high-dose steroids). 
• 
Any contraindication to ureteric stenting or flexible cystoscopy. 
• 
Patients unwilling or unable to comply with follow-up procedures. 
• 
Complex cases identified intra-op 
o 
Very large ureteric stone (>10mm), impacted stone, stone in intramural 
ureter, difficult stent, significant bleeding after stenting 
 
d. CONSENT  
 
Consent Process: 
• 
Initial contact will occur via phone or in person once a patient is identified on the 
elective surgical booking list for URS and stent exchange. 
• 
Consent obtained during preoperative consultation or on day of URS, prior to any 
study-specific procedures. 
• 
Informed consent will be obtained by the Principal Investigator or delegated 
urology registrar or resident medical officer who is listed on the Site Delegation 
Log. 
• 
The Participant Information Sheet and Consent Form (PICF) will be provided (via 
email, post, or hard copy) and explained to the patient during this contact. 
• 
On the day of surgery, prior to any study-related procedures and before anaesthesia, 
the participant will have the opportunity to ask questions. 
• 
Written informed consent will be obtained before proceeding with stent modification 
and data collection. 
 
Consent Documentation: 
• 
Signed original consent form retained in participant file. 
• 
Copy provided to participant. 
• 
Consent status recorded in secure database 
 
What will participants be told about the study? 
Participants will be informed of the following key elements: 

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• 
Study Background: 
o 
Ureteric stents are routinely used after URS for stone treatment. 
o 
Standard stents (Double-J) are associated with common symptoms like pain, 
urinary urgency, frequency, and discomfort. 
o 
This study is trialling a modified Single-J stent, created from an existing 
Bander Ureteral Stent, which may reduce these symptoms. 
• 
Study Purpose: 
o 
To evaluate if the modified SJS is safe, feasible, reduces stent symptoms, 
and does not migrate. 
• 
What Participation Involves: 
o 
Completing a USDT questionnaire before URS (while the standard DJS is in 
situ) and again before stent removal (with SJS in situ). 
o 
Undergoing the usual URS and stent insertion procedure, except the stent 
used will be modified. 
o 
Attending follow-up for flexible cystoscopy and stent removal (~7–10 days 
later), where migration will be assessed. 
o 
Participation lasts for approximately 2–3 weeks. 
• 
Risks: 
o 
Standard risks related to URS and stent use: 
▪ 
Haematuria 
▪ 
Dysuria 
▪ 
Urinary tract infection 
▪ 
Pain or discomfort 
▪ 
Stent migration (rare) 
o 
Specific risks of modified SJS: 
▪ 
Unknown risk of stent migration due to loss of distal loop 
▪ 
Limited existing data on patient outcomes using SJS 
▪ 
Possibility of needing an earlier intervention if complications arise (e.g. 
migration, pain) 
• 
Benefits: 
o 
Direct benefits to participants are not guaranteed. 

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o 
Potential for reduced stent symptoms and discomfort. 
o 
Contribution to research aimed at improving stent tolerability and quality of life 
for future patients. 
• 
Confidentiality: 
o 
Data will be securely stored and de-identified. 
o 
Results may be published, but participants will not be identifiable. 
• 
Right to Withdraw: 
o 
Participation is voluntary. 
o 
Participants may withdraw at any time without impact on their medical 
treatment or relationship with treating clinicians. 
7. PARTICIPANT SAFETY AND WITHDRAWAL  
a. RISK MANAGEMENT AND SAFETY 
 
• 
Known Risks: 
• 
Risks inherent to ureteroscopy (URS) and ureteral stenting include: 
o Haematuria (blood in urine) 
o Dysuria (painful urination) 
o Urinary tract infection (UTI) 
o Stent-related discomfort and pain 
o Potential stent migration or obstruction 
• 
Risks specifically related to the modified Single-J stent (SJS): 
o Possible increased risk of stent migration due to absence of distal loop 
o Unknown impact on urinary symptoms compared to standard Double-J 
stent (DJS) 
o Need for additional intervention if migration or obstruction occurs 
• 
Allergic or adverse reactions to materials are expected to be similar to those for 
standard stents. 
• 
Safety Monitoring: 
• 
Participants will be monitored closely post-URS and during stent removal 
cystoscopy. 

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• 
Any adverse events (AEs), serious adverse events (SAEs), or device-related 
complications will be documented and reported per institutional policy. 
• 
The clinical care team will manage all complications promptly, including the 
possibility of stent replacement or early removal. 
• An Adverse Event (AE) is any untoward medical occurrence in a participant. A 
Serious Adverse Event (SAE) is any event that results in death, is life-threatening, 
requires hospitalisation, or results in significant disability. 
• All SAEs will be reported to the Principal Investigator within 24 hours of site 
awareness. 
• The PI will report SAEs to the Austin Health HREC and Research Governance 
Office within required timelines (usually within 72 hours) as per institutional and 
NHMRC policy. 
• AEs will be recorded in the participant’s medical record and the study 
CRF/REDCap database. 
• Participants experiencing harm will receive appropriate medical care, and any 
study-related events will be documented and reviewed in safety monitoring. 
• 
Mitigation Strategies: 
• 
Only patients who have been pre-stented with standard DJS are included, 
providing baseline symptom comparison. 
• 
Migration will be directly visualized during cystoscopic stent removal, allowing 
timely intervention. 
• 
Participants will have clear instructions to report symptoms such as severe pain, 
fever, or signs of infection immediately. 
• 
Ethical and Regulatory Compliance: 
• 
The study follows Good Clinical Practice guidelines. 
• 
Safety data will be reviewed regularly by the Principal Investigator. 
• 
The study will be halted or modified if unacceptable safety concerns arise. 
 
b. HANDLING OF WITHDRAWALS  
• 
Participant Rights: 
• 
Participation is entirely voluntary. 
• 
Participants may withdraw from the study at any time and for any reason without 
penalty or loss of medical care. 
• 
Withdrawal Process: 

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• 
If a participant decides to withdraw, they will be asked (but not required) to 
provide a reason to improve study processes. 
• 
Participants withdrawing prior to stent removal will receive appropriate clinical 
follow-up and standard care. 
• 
Data Handling Upon Withdrawal: 
• 
Data collected up to the point of withdrawal will be retained and included in 
analyses unless the participant requests otherwise. 
• 
Withdrawal will be documented clearly in study records. 
• 
Early Study Withdrawal Criteria: 
• 
Participants may be withdrawn early for safety reasons, including but not limited 
to: 
o Severe adverse events related to the stent 
o Significant protocol violations 
o Investigator decision based on clinical judgment 
 
c. REPLACEMENTS 
 
• 
Replacement of Withdrawn Participants: 
• 
Participants who withdraw before completion of the study will not be replaced. 
• 
The study sample size calculation accounts for potential withdrawals and loss to 
follow-up to maintain statistical power. 
• 
Rationale: 
• 
Due to the nature of the intervention and follow-up timeline (~2–3 weeks), 
replacement recruitment may delay study completion and is not planned. 
 
8. STATISTICAL METHODS 
a. SAMPLE SIZE ESTIMATION & JUSTIFICATION   
• 
The study aims to detect a clinically meaningful difference in ureteral stent symptoms 
as measured by the USDT score between Double-J stent (DJS) and Single-J stent 
(SJS) within the same patients. 
• 
Based on prior similar studies using ureteral stent symptom questionnaires (e.g., 
Bostanci et al., Betschart et al.), a minimum detectable difference of approximately 
15% in symptom scores is considered clinically relevant. 

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• 
To account for within-subject paired comparisons and variability observed in previous 
trials, a sample size of 40 participants has been chosen. 
• 
This number provides sufficient precision for feasibility and exploratory objectives 
and allows for attrition or loss to follow-up. 
 
b. POWER CALCULATIONS  
• 
Assuming a two-sided significance level (alpha) of 0.05 and a power of 80%, the 
sample size of 45 achieves adequate power to detect a 15% difference in USDT 
scores between the two stent types. 
• 
This calculation assumes a moderate effect size (Cohen’s d approximately 0.5) 
based on variability reported in published ureteral stent symptom studies. 
• 
The paired design enhances statistical power by reducing inter-subject variability. 
 
c. STATISTICAL METHODS TO BE UNDERTAKEN 
• 
Primary Analysis: 
• 
Comparison of USDT scores with DJS and SJS within participants using the 
paired t-test for normally distributed data. 
• 
If normality assumptions are violated, the Wilcoxon signed-rank test will be 
applied. 
• 
Secondary Analysis: 
• 
Migration rates (categorical) will be summarized using frequencies and 
percentages. 
• 
Associations between migration and baseline characteristics will be examined 
using Chi-square or Fisher’s exact tests. 
• 
Descriptive Statistics: 
• 
Demographics and baseline characteristics will be summarized with means ± SD, 
medians and IQR, or counts and percentages as appropriate. 
• 
Missing Data: 
• 
Complete-case analysis will be primary. 
• 
Sensitivity analyses with multiple imputation will be performed if missingness 
exceeds 5%. 
• 
Statistical significance: Set at p < 0.05. 
• 
Software: Analyses performed using SPSS, Stata, or R. 
 

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9. STORAGE OF BLOOD AND TISSUE SAMPLES 
a. DETAILS OF WHERE SAMPLES WILL BE STORED, AND THE TYPE OF 
CONSENT FOR FUTURE USE OF SAMPLES 
Not applicable 
10. 
  DATA SECURITY & HANDLING 
a. DETAILS OF WHERE RECORDS WILL BE KEPT & HOW LONG WILL 
THEY BE STORED 
• 
All study-related records, including electronic case report forms (eCRFs), will be 
securely stored in a REDCap (Research Electronic Data Capture) database hosted on 
a secure institutional server. 
• 
Physical documents such as signed consent forms will be stored in locked filing cabinets 
within restricted-access areas of the study site. 
• 
Data will be retained for a minimum of 15 years following study completion, in 
accordance with institutional policies and relevant regulations. 
• 
After the retention period, data will be securely destroyed or anonymized to protect 
participant confidentiality. 
 
b. CONFIDENTIALITY AND SECURITY  
• 
Participant data entered into REDCap will be identified only by a unique study ID 
number; no personally identifiable information will be included in the database. 
• 
Access to the REDCap system is restricted to authorized study personnel via secure 
login credentials. 
• 
All data transfers will use encrypted connections (HTTPS/SSL) to maintain 
confidentiality. 
• 
Data handling will comply with institutional data protection policies and applicable 
privacy legislation (e.g., GDPR or local equivalents). 
• 
Any paper-based records will be handled in accordance with confidentiality protocols 
and kept in locked cabinets within secure facilities. 
 
c. ANCILLARY DATA 
• 
Additional data collected for ancillary analyses (e.g., demographic, clinical baseline 
data, procedure details, ureter length measured from Computed Tomography) will be 
stored alongside primary outcome data within the REDCap database. 
• 
Ancillary data will be governed by the same confidentiality and retention policies as the 
main study data 
11. 
REFERENCES 
 

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1. Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. 
Ureteral 
Stent 
Symptom 
Questionnaire: 
development 
and 
validation 
of 
a 
multidimensional quality of life measure. J Urol. 2003;169(3):1060-1064. 
2. Bosio A, Alessandria E, Agosti S, et al. Prospective randomized trial of commercial 
single-J suture stent vs double-J stent after ureteroscopy: impact on stent-related 
symptoms. World J Urol. 2021. 
3. Yang K, Li X, Wang G. A “bridge” technique to replace the obstructed single-J stent in 
patients with ileal conduit urinary diversion: a case report. Transl Androl Urol. 2021. 
4. Bach P, Reicherz A, Teichman J, et al. Short-term external ureter stenting shows benefit 
compared to routine double-J stent placement after ureterorenoscopic stone extraction: 
FaST trial. Int J Urol. 2018. 
5. Ooms LSS, Spaans LG, Betjes MGH, Ijzermans JNM, Terkivatan T. Minimizing 
urological complications after kidney transplant: comparing two external ureteral stents. 
Exp Clin Transplant. 2017. 
6. Lai D, He Y, Dai Y, et al. Long-forgotten indwelling single-J stent in transplant kidney: 
endoscopic management. Transplant Proc. 2013. 
7. REDCap Consortium. REDCap – Research Electronic Data Capture. J Biomed Inform. 
2009. 
8. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: 
guidelines for reporting randomized trials. BMJ. 2010.