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

NCT05100017 | Active Not Recruiting

• 1 other identifier: STU00214901
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Calculi; Kidney Diseases; Nephrolithiasis; Urolithiasis; Ureteral Diseases; Ureteral Calculi

Outcome Measures

Primary Outcomes (2)

• Patient discomfort/pain after ureteroscopy and ureteral stent placement

  Patients will be administered the VAS pain scale to assess pain scores (score from 1-10). The VAS pain scale will be administered at the time of study enrollment, daily from POD1 until the day of stent removal, and 1 day after the stent is removed.

  1 week

• Patient ureteral stent symptoms after ureteroscopy and ureteral stent placement

  Patients will be administered the PROMIS questionnaire, which has been validated for assessing ureteral stent symptoms. The questionnaire will be administered at the time of study enrollment, daily from POD1 until the day of stent removal, and 1 day after the stent is removed.

  1 week

Study Arms (2)

Methocarbamol

ACTIVE COMPARATOR

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).

Drug: Methocarbamol

Oxybutynin

ACTIVE COMPARATOR

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).

Drug: Oxybutynin

Interventions

Methocarbamol DRUG

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

Methocarbamol

Oxybutynin DRUG

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

Oxybutynin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between age 18-80 years who are diagnosed with stones who undergo ureteroscopy and ureteral stent placement.
• 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.
• Willing to take only diclofenac (or tramadol for patients with contraindication to diclofenac), phenazopyridine, and acetaminophen for post stent placement discomfort.
• Willing to sign the Informed Consent Form.
• Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.

You may not qualify if:

• Active, symptomatic urinary tract infection.
• Non-stone related ureteral obstruction or stricture.
• Procedural trauma or significant retained stone burden that could significantly contribute to patient discomfort.
• Spinal cord injuries (sensory loss due to injury).
• Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively.
• Chronic opioid usage for pain.
• Members of vulnerable patient populations.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Kidney Diseases; Nephrolithiasis; Urolithiasis; Ureteral Diseases; Ureteral Calculi

Interventions

Methocarbamol; oxybutynin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: September 30, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-07

Locations

US (1)