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CompletedNCT06830902COMFIJUpdated Oct 1, 2026

Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent

An interventional study of Regular Double J stent and Comfi J stent in Stent Related Symptoms, sponsored by Bir Hospital. Completed at 1 site in Nepal. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Bir Hospital · Not applicable, Interventional, and Prevention

Updated Oct 1, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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-

  1. Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.
  2. Compare Visual Analog Scale (VAS) pain scores.
  3. Assess complications associated with each stent.
  4. 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

02

Conditions studied

  • Stent Related Symptoms
03

In context

Lead sponsor

Bir Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Concomitant use of a-blockers, anticholinergics, , 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Regular Double J stent

    Regular Double J stent placement

    Device: Regular Double J stent

  • Active comparator
    Comfi J stent

    Comfi J stent placement

    Device: Comfi J stent

Interventions

  • DeviceRegular Double J stent

    Regular Double J stent

  • DeviceComfi J stent

    Comfi J stent

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: before 2 weeks

07

Study locations

1 site
  • Bir Hospital
    Kathmandu, Bagmati 44600, Nepal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jun 2025 to primary completion in Feb 2026, 8 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: start Feb 2025 → Jun 2025, primary completion Aug 2025 → Feb 2026 and completion Sep 2025 → Mar 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2025
First posted
Feb 17, 2025
StartActual
Jun 1, 2025was Feb 2025
Primary completionActual
Feb 28, 2026was Aug 2025
CompletionActual
Mar 30, 2026was Sep 2025
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Oct 1, 2026
Start date
Feb 15, 2025→Jun 1, 2025 (actual)
Oct 1, 2026
Primary completion
Aug 15, 2025→Feb 28, 2026 (actual)
Oct 1, 2026
Study completion
Sep 15, 2025→Mar 30, 2026 (actual)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Not yet recruiting→Completed
    Start date Feb 15, 2025→Jun 1, 2025 (now actual)
    Primary completion Aug 15, 2025→Feb 28, 2026 (now actual)
    Study completion Sep 15, 2025→Mar 30, 2026 (now actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06830902
Lead sponsor
Bir Hospital
Collaborators
Nepal Health Research Council
Responsible party
Anil Shrestha (Professor Dr., Bir Hospital) — Principal investigator
First posted
Feb 17, 2025
Start date
Jun 1, 2025
Primary completion
Feb 28, 2026
Completion
Mar 30, 2026
Last update
Oct 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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