Clinical trial NCT06830902: Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent
Official title: Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stent Related Symptoms
Lead sponsor: Bir Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Nepal Health Research Council
First posted: 2025-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind, Randomised controlled trial
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Stent related symptom
timeFrame: 2 weeks
Secondary outcomes:
measure: Complication rates
timeFrame: before 2 weeks
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Bir Hospital
state: Bagmati
Study officials:
References: