What side effects are associated with this type of intervention?

Methocarbamol, used as an anti-spasmodic muscle relaxant, can cause side effects such as dizziness, drowsiness, nausea, and headache. Oxybutynin, an anticholinergic that relaxes bladder muscles, has a broader range of side effects including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and potential cognitive effects like confusion or dementia. Overall, methocarbamol tends to have fewer and less severe side effects compared to oxybutynin.

What prior FDA approvals exist?

The FDA has approved various medications for the management of symptoms related to kidney stones, particularly those that alleviate pain and reduce muscle spasms. Anticholinergic drugs like Oxybutynin, which relax bladder muscles, are commonly used to manage bladder spasms and discomfort associated with ureteral stents post-ureteroscopy. Additionally, alpha blockers and NSAIDs are frequently prescribed to reduce stent-related morbidity by decreasing muscle spasms and inflammation. Methocarbamol, an anti-spasmodic muscle relaxant, is being studied for its potential to provide superior analgesia for stent-related bladder spasms compared to anticholinergics like Oxybutynin.

What other types of research exist?

Promising alternatives to Methocarbamol and Oxybutynin for kidney stone patients include alpha blockers (e.g., tamsulosin) and NSAIDs for reducing stent morbidity. Additionally, botulinum toxin injections and sacral neuromodulation are novel treatments that may offer effective symptom management with potentially fewer side effects.

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Methocarbamol vs Oxybutynin for Pain After Kidney Stone Procedure

N/A

Recruiting

Research Sponsored by Northwestern University

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

Must not have

Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively

Procedural trauma or significant retained stone burden that could significantly contribute to patient discomfort

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial compares Methocarbamol and Oxybutynin for pain relief after stone removal surgery. It targets patients with a ureteral stent placed post-surgery. Methocarbamol helps calm down muscle spasms, while Oxybutynin relaxes the bladder to reduce discomfort.

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.

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.

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 below

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I am between 18-80 years old and have had a stent placed due to kidney stones.

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I agree to only use diclofenac, tramadol (if diclofenac is unsuitable), phenazopyridine, and acetaminophen for post-stent discomfort.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I needed a tube to help me urinate for more than a day after surgery, not because of kidney stones.

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I have pain from surgery or remaining kidney stones.

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I have a blockage in my ureter that is not caused by a stone.

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I currently have symptoms of a urinary tract infection.

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I have sensory loss due to a spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient discomfort/pain after ureteroscopy and ureteral stent placement

Patient ureteral stent symptoms after ureteroscopy and ureteral stent placement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Methocarbamol is an anti-spasmodic muscle relaxant that acts on central neurons and may block sodium channels, helping to reduce muscle spasms and pain associated with ureteral stents. Oxybutynin, an anticholinergic, relaxes bladder muscles, reducing urgency and frequency of urination caused by stent irritation. These mechanisms are important for kidney stone patients as they aid in selecting treatments that effectively manage pain and discomfort while minimizing side effects.

The effect of verapamil on the treatment of detrusor hyperreflexia in the spinal cord injured population.Comparison of the inhibitory effects of cromakalim and pinacidil (potassium channel openers) with those of oxybutynin on stimulated guinea pig and rabbit detrusor muscle strips.