NCT06635889 Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
| NCT ID | NCT06635889 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Chicago |
| Condition | Nephrolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 116 participants in total. It began in 2025-03-26 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy. This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, aged ≥ 18 years old. * Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting. Exclusion Criteria: * Foley catheterization * History of allergy to bupivacaine * Antegrade ureteroscopy * Transplant or ectopic kidney * Ureteral or bladder reconstruction * Pregnancy (which is a contraindication to elective ureteroscopy) * Dialysis * Surgical complication (significant bleeding, ureteral perforation, significant urothelial damage) * Suspicion of untreated urinary tract infection * History of pelvic radiation * Neurologic disease with a diagnosis of neurogenic bladder dysfunction * History of chronic pain (fibromyalgia, interstitial cystitis, opioid abuse)
Contact & Investigator
Luke Reynolds, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06635889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephrolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06635889 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06635889 currently recruiting?
Yes, NCT06635889 is actively recruiting participants. Contact the research team at lukereynolds@bsd.uchicago.edu for enrollment information.
Where is the NCT06635889 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06635889 clinical trial?
NCT06635889 is sponsored by University of Chicago. The principal investigator is Luke Reynolds, MD at University of Chicago. The trial plans to enroll 116 participants.