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

ConditionStent Related Symptoms

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBir Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Regular Double J stent
Device
Regular Double J stent
Comfi J stent
Device
Comfi J stent

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Regular Double J stentActive comparator 1 intervention

Group B: Comfi J stentActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

2 weeks

Secondary outcomes

Complication rates

Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.

Time frame

before 2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bir Hospital

Lead sponsor

Nepal Health Research Council

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: