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NCT Number: NCT06830902

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • 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

Treatment and study plan

Regular Double J stent

Device

Regular Double J stent

Comfi J stent

Device

Comfi J stent

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complication rates

    Time frame: before 2 weeks

    Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Anil Shrestha, M Ch Urology

CONTACT

[email protected]

009779851092274

Udita Mishra, M Ch Urology

CONTACT

[email protected]

009779841389895

Sponsors and collaborators

Lead sponsor

Bir Hospital

Other Gov

Collaborators

  • Nepal Health Research Council

Registry information

Official study title

Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial

Acronym: COMFIJ

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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