Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent
NCT ID: NCT06830902
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-02-15
2025-09-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Regular Double J stent
Regular Double J stent placement
Regular Double J stent
Regular Double J stent
Comfi J stent
Comfi J stent placement
Comfi J stent
Comfi J stent
Interventions
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Regular Double J stent
Regular Double J stent
Comfi J stent
Comfi J stent
Eligibility Criteria
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Inclusion Criteria
* Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Nepal Health Research Council
OTHER_GOV
Bir Hospital
OTHER_GOV
Responsible Party
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Anil Shrestha
Professor Dr.
Locations
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Bir Hospital
Kathmandu, Bagmati, Nepal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ComfiJ
Identifier Type: -
Identifier Source: org_study_id
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