Stent Related SymptomsCOMFIJNCT06830902
Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent
A study testing Regular Double J stent and Comfi J stent in people with Stent Related Symptoms, run by Bir Hospital at 1 site in Nepal.
Trial summary
A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stent Related Symptoms
- What is being tested?
- Regular Double J stent and Comfi J stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were adult patients (aged 18-80 years) who underwent unilateral retrograde ureteroscopy (URS) lithotripsy for stone disease
- Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones
Who cannot join
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Overactive bladder syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
- A single kidney
Show all 12Show fewer
- Moderate or severe cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the USSQ pain score
- Allergy to any medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores.
Read the detailed description
Ureteral stents are widely used in urology following retrograde intrarenal surgeries and ureteric lithotripsy and other endourological procedures. However, their use is associated with significant discomfort, infections, and reduced quality of life (QoL). Over time, different materials and designs have been developed to improve stent performance and reduce complications. This study aims to compare the stent-related symptoms (SRS) of two types of ureteral stents: the regular Double J stent and the Comfi J stent.
Objectives of the study-
- Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.
- Compare Visual Analog Scale (VAS) pain scores.
- Assess complications associated with each stent.
- Evaluate the difficulty of stent insertion.
Study Design \& Methods: A prospective, single-blinded, randomized controlled trial conducted at a single center. Sample Size: 100 patients undergoing retrograde intrarenal surgery, ureteroscopic lithotripsy
Randomization: Intraoperative, using a computer-generated sequence, block randomization Assessments: USSQ and VAS scores at post-operative days (POD) 1, 7, and 14.
Statistical Analysis: Statistical Package for the Social Sciences software with a significance threshold of p < 0.05.
Expected Outcomes: Determining whether the Comfi J stent reduces pain, urinary symptoms, and other complications compared to the regular Double J stent.
Evaluating if changes in design/material can improve patient QoL.
Ethical Considerations:
Institutional ethics approval and informed consent from all participants. Confidentiality ensured, with voluntary participation.
This study aims to provide evidence-based recommendations for improving ureteral stent tolerability and reducing patient morbidity
- Conditions
- Stent Related Symptoms
- Being tested
- Regular Double J stent, Comfi J stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Double J stentDevice
Regular Double J stent
Comfi J stentDevice
Comfi J stent
| Study group | Role | What they receive |
|---|---|---|
| Regular Double J stent | Active comparator | Regular Double J stent placement Receives: Device: Regular Double J stent |
| Comfi J stent | Active comparator | Comfi J stent placement Receives: Device: Comfi J stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent related symptom
Comparison of Ureteral Stent Symptom Questionnaire (USSQ) scores between regular Double J stent and Comfi J stent at postoperative day 1, 7, and 14. Higher Scores means greater severity of the symptoms.
Measured: 2 weeks
Secondary outcomes (1)
Complication rates
Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.
Measured: before 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Jun 2025
- Primary completion28 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent Related SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind, Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bir Hospital
- Sponsor type
- Other government
- Collaborators
- Nepal Health Research Council
- Responsible party
- Principal investigator, Anil Shrestha, Bir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830902
- Sponsor's protocol ID
- ComfiJ
- Acronym
- COMFIJ
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06830902
- Acronym / sponsor ID
- COMFIJ / ComfiJ
- Conditions
- Stent Related Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bir HospitalOther government
- Collaborators
- Nepal Health Research Council
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores.
Detailed description
Ureteral stents are widely used in urology following retrograde intrarenal surgeries and ureteric lithotripsy and other endourological procedures. However, their use is associated with significant discomfort, infections, and reduced quality of life (QoL). Over time, different materials and designs have been developed to improve stent performance and reduce complications. This study aims to compare the stent-related symptoms (SRS) of two types of ureteral stents: the regular Double J stent and the Comfi J stent.
Objectives of the study-
- Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.
- Compare Visual Analog Scale (VAS) pain scores.
- Assess complications associated with each stent.
- Evaluate the difficulty of stent insertion.
Study Design \& Methods: A prospective, single-blinded, randomized controlled trial conducted at a single center. Sample Size: 100 patients undergoing retrograde intrarenal surgery, ureteroscopic lithotripsy
Randomization: Intraoperative, using a computer-generated sequence, block randomization Assessments: USSQ and VAS scores at post-operative days (POD) 1, 7, and 14.
Statistical Analysis: Statistical Package for the Social Sciences software with a significance threshold of p < 0.05.
Expected Outcomes: Determining whether the Comfi J stent reduces pain, urinary symptoms, and other complications compared to the regular Double J stent.
Evaluating if changes in design/material can improve patient QoL.
Ethical Considerations:
Institutional ethics approval and informed consent from all participants. Confidentiality ensured, with voluntary participation.
This study aims to provide evidence-based recommendations for improving ureteral stent tolerability and reducing patient morbidity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blind, Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Regular Double J stent | Active comparator | Device: Regular Double J stentRegular Double J stent placement |
| Comfi J stent | Active comparator | Device: Comfi J stentComfi J stent placement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants were adult patients (aged 18-80 years) who underwent unilateral retrograde ureteroscopy (URS) lithotripsy for stone disease
- Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones
Key exclusion criteria (12 listed)
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Overactive bladder syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Double J stentRegular Double J stent | Device | Regular Double J stent |
| Comfi J stentComfi J stent | Device | Comfi J stent |
Primary outcome
Stent related symptom
Time frame: 2 weeks
Comparison of Ureteral Stent Symptom Questionnaire (USSQ) scores between regular Double J stent and Comfi J stent at postoperative day 1, 7, and 14. Higher Scores means greater severity of the symptoms.
1 secondary outcome
Complication rates
Time frame: before 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Double J stent and Comfi J stent in people with Stent Related Symptoms, run by Bir Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent related symptom (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.