Bir Hospital
Kathmandu, Bagmati, 44600, Nepal
Location contact
Anil Shrestha, M Ch Urology
CONTACT
Udita Mishra, M Ch Urology
CONTACT
NCT Number: NCT06830902
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Kathmandu, Bagmati, 44600, Nepal
Anil Shrestha, M Ch Urology
CONTACT
Udita Mishra, M Ch Urology
CONTACT
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-
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regular Double J stent
Comfi J stent
Time frame: 2 weeks
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.
Time frame: before 2 weeks
Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.
Contact information is provided by the study sponsor or research team.
Anil Shrestha, M Ch Urology
CONTACT
Udita Mishra, M Ch Urology
CONTACT
Bir Hospital
Other Gov
Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
Acronym: COMFIJ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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