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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women between age 18-80 years who are diagnosed with stones and undergo ureteroscopy and ureteral stent placement
Willing to take only diclofenac (or tramadol for patients with contraindication to diclofenac), phenazopyridine, and acetaminophen for post stent placement discomfort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study Summary
This trialevaluates the efficacy and safety of treating upper tract stone disease with methocarbamol vs. oxybutynin post-ureteroscopy, to reduce stent-related morbidity.
Who is the study for?
This trial is for men and women aged 18-80 who have kidney stones, are undergoing ureteroscopy with stent placement, and can consent to treatment. Participants must be willing to take specific pain control drugs post-surgery and complete questionnaires. Those with non-stone related urinary issues, active infections, procedural trauma, chronic opioid use or spinal cord injuries cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness of Methocarbamol (a muscle relaxant) versus Oxybutynin (used for overactive bladder) in managing pain after a ureteroscopy procedure. Both groups will also receive standard care medications for pain control alongside their assigned study drug.See study design
What are the potential side effects?
Oxybutynin may cause dry mouth/eyes, constipation, urinary retention, blurred vision or even dementia. Methocarbamol's side effects aren't detailed here but typically include dizziness, headache, fever/chills; it acts on central neurons and may block sodium channels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18-80 years old and have had a stent placed due to kidney stones.
Select...
I agree to only use diclofenac, tramadol (if diclofenac is unsuitable), phenazopyridine, and acetaminophen for post-stent discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient discomfort/pain after ureteroscopy and ureteral stent placement
Patient ureteral stent symptoms after ureteroscopy and ureteral stent placement
Trial Design
2Treatment groups
Active Control
Group I: MethocarbamolActive Control1 Intervention
Patients will receive oral Methocarbamol 750mg every six hours after ureteroscopy as needed for pain in addition to the standard postoperative pain regimen (Tylenol 1000mg every six hours, Tamsulosin 0.4mg daily, phenazopyridine 200mg every eight hours, and diclofenac 50mg every eight hours).
Group II: OxybutyninActive Control1 Intervention
Patients will receive oral Oxybutynin XL 10mg daily after ureteroscopy as needed for pain in addition to the standard postoperative pain regimen (Tylenol 1000mg every six hours, Tamsulosin 0.4mg daily, phenazopyridine 200mg every eight hours, and diclofenac 50mg every eight hours).
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
916,855 Total Patients Enrolled
5 Trials studying Kidney Stones
484 Patients Enrolled for Kidney Stones
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