RecruitingNot ApplicableNCT05100017

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


Sponsor

Northwestern University

Enrollment

126 participants

Start Date

Sep 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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. Anticholinergic drugs are also utilized as they decrease bladder spasms and, therefore, are hypothesized to reduce stent irritation. However, the evidence for anticholinergics has been conflicting. Anticholinergics also have a serious side effect profile including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and even dementia. Some authors even hypothesize that these side effects may offset any purported benefits the anticholinergics provide for stent-morbidity. Methocarbamol is anti-spasmodic muscle relaxant that is believed to work by acting on central neurons and possibly by blocking sodium channels. Given that anticholinergics have many side effects and questionable efficacy, the investigators hypothesize that methocarbamol may achieve superior analgesia for stent morbidity and stent-related bladder spasms. Oxybutynin is used for the treatment of overactive bladder. The rationale is that the oxybutynin relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination caused by the urinary stent irritation. Since anticholinergics have multiple side effects, finding an equally efficacious alternative with less side effects is highly desirable. This study will evaluate the clinical and demographic factors of patients undergoing ureteroscopy and treated postoperatively with methocarbamol vs. oxybutynin for stent-related morbidity. Additionally, the study will aim to understand the postoperative outcomes and complication rates of patients discharged with methocarbamol vs. oxybutynin after ureteroscopy with a ureteral stent in place.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

After a ureteroscopy (a procedure to remove kidney stones with a small camera), many patients experience pain and discomfort from the temporary stent placed in the ureter. This study compares two medications — methocarbamol (a muscle relaxant) and oxybutynin (a bladder-calming drug) — to see which works better at controlling that post-procedure discomfort. You may be eligible if: • You are 18 to 80 years old • You have been diagnosed with kidney stones • You are having a ureteroscopy procedure with ureteral stent placement • You are willing to be randomly assigned to one of the two study medications • You can read, understand, and complete questionnaires and a medication diary You may NOT be eligible if: • You have an active urinary tract infection with symptoms • Your ureteral obstruction is caused by something other than a stone • You have a spinal cord injury affecting sensation • You take opioids regularly for chronic pain • You are part of a vulnerable patient population • You had significant complications or retained stone burden during the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethocarbamol

Patients will receive oral Methocarbamol 750mg every six hours as needed for pain post ureteroscopy in addition to the standard postoperative pain regimen.

DRUGOxybutynin

Patients will receive oral Oxybutynin XL 10mg daily for pain post ureteroscopy in addition to the standard postoperative pain regimen.


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT05100017


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