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New treatment option for Nephrolithiasis
Official title Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
ClinicalTrials.gov ID: NCT06635889
What this study is testing
What is Bupivacaine?
Bupivacaine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for nephrolithiasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.