Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regular Double J stent, Comfi J stent.
- Who it may be relevant to
- Registry conditions: Stent Related Symptoms. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nepal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
Overview
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-
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
Interventions
- Device Regular Double J stent
Regular Double J stent - Device Comfi J stent
Comfi J stent
Primary outcome measures
- Stent related symptom [Time frame: 2 weeks]
Secondary outcome measures (1)
- Complication rates [Time frame: before 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Nepal · 1 center
- Bir Hospital — Kathmandu
Identifiers
NCT: NCT06830902 · ComfiJ