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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stent Related Symptoms
• Intervention / Treatment: Device: Regular Double J stent; Device: Comfi J stent

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anil Shrestha, M Ch Urology; Phone Number: 009779851092274; Email: anyl77@hotmail.com
• Study Contact Backup: Name: Udita Mishra, M Ch Urology; Phone Number: 009779841389895; Email: uditamishra2014@gmail.com

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Bir Hospital
      • Contact: Anil Shrestha, M Ch Urology; Phone Number: 009779851092274; Email: anyl77@hotmail.com
      • Contact: Udita Mishra, M Ch Urology; Phone Number: 009779841389895; Email: uditamishra2014@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Double J stent; Regular Double J stent placement	Device: Regular Double J stent; Regular Double J stent
Active Comparator: Comfi J stent; Comfi J stent placement	Device: Comfi J stent; Comfi J stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rates	Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.	before 2 weeks

Collaborators and Investigators

• Sponsor: Bir Hospital
• Collaborators: Nepal Health Research Council

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): August 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ComfiJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No