Comparing Methocarbamol and Oxybutynin for Pain Relief After Ureteroscopy
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
This study tests whether Methocarbamol or Oxybutynin can help people feel less pain after having kidney stones removed with a procedure called ureteroscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05100017 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two medications, Methocarbamol and Oxybutynin, in managing pain and discomfort following ureteroscopy for kidney stone removal. Patients undergoing the procedure will be randomly assigned to receive either medication in addition to a standard postoperative pain management regimen. The goal is to determine which medication provides better pain relief and reduces the need for emergency care due to stent-related discomfort. Both medications are FDA approved but will be used off-label for this purpose.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-80 who are diagnosed with kidney stones and are scheduled for ureteroscopy with ureteral stent placement.
Not a fit: Patients with active urinary tract infections or non-stone related ureteral obstructions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing ureteroscopy, enhancing their recovery experience.
How similar studies have performed: While there have been various approaches to managing stent-related pain, this specific comparison of Methocarbamol and Oxybutynin is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women between age 18-80 years who are diagnosed with stones who undergo ureteroscopy and ureteral stent placement. 2. Patients who consent to the procedure will be randomized in 1:1 fashion by RedCAP either to the methocarbamol or oxybutynin arm. All patients will receive standard of care diclofenac, tamsulosin, and pyridium for pain control plus one of the study drugs. 3. Willing to take only diclofenac (or tramadol for patients with contraindication to diclofenac), phenazopyridine, and acetaminophen for post stent placement discomfort. 4. Willing to sign the Informed Consent Form. 5. Able to read, understand, and complete patient questionnaires, pain texts, and medication diary. Exclusion Criteria: 1. Active, symptomatic urinary tract infection. 2. Non-stone related ureteral obstruction or stricture. 3. Procedural trauma or significant retained stone burden that could significantly contribute to patient discomfort. 4. Spinal cord injuries (sensory loss due to injury). 5. Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively. 6. Chronic opioid usage for pain. 7. Members of vulnerable patient populations.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Allaa Fadl-Alla
- Email: allaa.fadlalla@northwestern.edu
- Phone: 3126958146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.