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

NCT06830902 | Not Yet Recruiting

• 1 other identifier: ComfiJ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stent Related Symptoms

Outcome Measures

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.

  2 weeks

Secondary Outcomes (1)

• Complication rates

  before 2 weeks

Study Arms (2)

Regular Double J stent

ACTIVE COMPARATOR

Regular Double J stent placement

Device: Regular Double J stent

Comfi J stent

ACTIVE COMPARATOR

Comfi J stent placement

Device: Comfi J stent

Interventions

Regular Double J stent DEVICE

Regular Double J stent

Regular Double J stent

Comfi J stent DEVICE

Comfi J stent

Comfi J stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bir Hospital: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

Bir Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Central Study Contacts

Anil Shrestha, M Ch Urology

CONTACT

009779851092274; anyl77@hotmail.com

Udita Mishra, M Ch Urology

CONTACT

009779841389895; uditamishra2014@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: Single Blind, Randomised controlled trial

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: February 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)