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Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure


Description

Stone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment for upper tract stone disease. Ureteral stenting is a common practice after ureteroscopy and placed in \~75% of cases to prevent ureteral edema and renal obstruction. Unfortunately, ureteral stenting can be very painful and has been shown to increase the rate of emergency room visits. Many strategies have been attempted to decrease pain with ureteral stenting including modification of stent material and designs, but efforts so far have been unsuccessful in decreasing stent-related morbidity. Stent-related morbidity is hypothesized to be secondary to irritation of ureteral/bladder mucosa and muscle. Analgesics such as alpha blockers and NSAIDs have been shown to reduce stent morbidity. Antich

Trial Eligibility

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.

Study Info

Organization

Northwestern University


Primary Outcome

Patient discomfort/pain after ureteroscopy and ureteral stent placement


Outcome Timeframe 1 week

NCTID NCT05100017

Phases NA

Primary Purpose TREATMENT

Start Date 2021-09-30

Completion Date 2025-02

Enrollment Target 126

Interventions

DRUG Methocarbamol

DRUG Oxybutynin

Locations Recruiting

Northwestern University

United States, Illinois, Chicago


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