126 Participants Needed

Methocarbamol vs Oxybutynin for Pain After Kidney Stone Procedure

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Overseen ByAlyssa Mcdonald
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
Must be taking: Diclofenac, Tramadol, Phenazopyridine, Acetaminophen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medicines, methocarbamol and oxybutynin, to determine which better reduces pain from a stent after a kidney stone procedure. A ureteral stent, placed post-procedure, often causes discomfort and bladder spasms. Methocarbamol, a muscle relaxant, might ease these spasms without the side effects commonly associated with oxybutynin, which currently relaxes bladder muscles. Individuals who have undergone ureteroscopy with a stent and experience post-procedure pain may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-procedure comfort for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you must be willing to take only diclofenac (or tramadol if you can't take diclofenac), phenazopyridine, and acetaminophen for post-stent placement discomfort.

Will I have to stop taking my current medications?

The trial requires participants to take only specific medications for pain control after the procedure, including diclofenac (or tramadol if diclofenac is not suitable), phenazopyridine, and acetaminophen. You may need to stop other pain medications, but the protocol does not specify about other types of medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that methocarbamol is usually well-tolerated and relieves muscle spasms. Some people experience mild side effects such as sleepiness, dizziness, or nausea. Those with kidney or liver problems should exercise caution, as the medication might remain in the body longer.

Oxybutynin treats an overactive bladder by relaxing bladder muscles. While it reduces bladder spasms, it can cause side effects like dry mouth, constipation, and blurred vision. Some studies suggest it may also reduce the need for painkillers after surgery.

Both treatments are widely used and considered safe in many situations. For concerns about side effects or specific health conditions, consulting a healthcare provider is advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer alternative approaches for managing pain after kidney stone procedures. Methocarbamol is a muscle relaxant that targets muscle spasms, which can be a source of discomfort following ureteroscopy. On the other hand, Oxybutynin is traditionally used for bladder issues and works by relaxing bladder muscles, potentially easing pain by reducing spasms in the urinary tract. Both treatments provide a different mechanism of action compared to standard pain management options like opioids or NSAIDs, and they may help minimize the need for stronger pain medications with more side effects.

What evidence suggests that this trial's treatments could be effective for pain after a kidney stone procedure?

This trial will compare the effectiveness of Methocarbamol and Oxybutynin for pain management after kidney stone surgery. Research has shown that Methocarbamol, a muscle relaxant, may ease pain from ureteral stents by calming nerve signals and possibly blocking certain channels, reducing muscle spasms. Participants in one arm of the trial will receive Methocarbamol. Oxybutynin, another medication under study, is often used to treat an overactive bladder by relaxing bladder muscles. Studies have found that Oxybutynin can effectively reduce bladder spasms and pain from ureteral stents, though it may cause side effects like dry mouth and constipation. Participants in another arm of the trial will receive Oxybutynin. The trial aims to compare the effectiveness of both treatments to determine the best way to reduce pain and discomfort after kidney stone surgery.12678

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to sign the Informed Consent Form
I agree to only use diclofenac, tramadol (if diclofenac is unsuitable), phenazopyridine, and acetaminophen for post-stent discomfort.
I agree to be randomly assigned to a study group and will take standard pain control medications plus a study drug.
See 1 more

Exclusion Criteria

I needed a tube to help me urinate for more than a day after surgery, not because of kidney stones.
I have pain from surgery or remaining kidney stones.
Chronic opioid usage for pain
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Methocarbamol or Oxybutynin for pain management after ureteroscopy, along with a standard postoperative pain regimen

1 week
Daily virtual check-ins via text message

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ureteral stent symptoms and pain

1 week
1 visit (in-person) for stent removal

What Are the Treatments Tested in This Trial?

Interventions

  • Methocarbamol
  • Oxybutynin
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: MethocarbamolActive Control1 Intervention
Group II: OxybutyninActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Published Research Related to This Trial

In a study of 66 patients with ureteral stones, the use of isosorbide-SR 40 mg did not significantly improve the stone expulsion rate compared to the control group (54.5% vs. 45.5%).
Patients receiving isosorbide-SR experienced more side effects, including intractable pain and headaches, suggesting that it may not be a suitable option for medical expulsive therapy in ureteral stones.
Randomized controlled trial of the efficacy of isosorbide-SR addition to current treatment in medical expulsive therapy for ureteral calculi.Hamidi Madani, A., Kazemzadeh, M., Pourreza, F., et al.[2021]
In a study of 66 patients with distal ureteral stones, doxazosin at both 4 mg and 8 mg doses effectively increased stone expulsion rates compared to a control group, with rates of 72% and 68.1% respectively, versus only 25.3% in the control group.
Doxazosin was found to significantly reduce pain episodes and the need for analgesics in patients, with no significant difference in efficacy between the two doses, suggesting that the lower 4 mg dose is sufficient for effective medical expulsive therapy.
A comparison of efficacy of doxazosin 4 and 8 mg in medical expulsive therapy of distal ureteral stones: a prospective randomized clinical trial.Sen, H., Erturhan, S., Sadioglu, E., et al.[2018]
A network meta-analysis of 26 studies involving 2775 patients found that doxazosin and tamsulosin are the most effective medications for promoting the expulsion of urinary stone fragments after extracorporeal shock wave lithotripsy (ESWL).
Doxazosin showed superior long-term effectiveness in improving stone-free rates, while tamsulosin was more effective in accelerating the expulsion process in the short term.
A network meta-analysis on the beneficial effect of medical expulsive therapy after extracorporeal shock wave lithotripsy.Yang, TX., Liao, BH., Chen, YT., et al.[2019]

Citations

Methocarbamol vs Oxybutynin for Management of Pain and ...This study is comparing the effectiveness of pain control after ureteroscopy for stone removal between two medications: oral Oxybutynin XL 10mg daily and ...
Methocarbamol vs Oxybutynin for Pain After Kidney Stone ...This trial compares Methocarbamol and Oxybutynin for pain relief after stone removal surgery. It targets patients with a ureteral stent placed post-surgery.
Comparing Methocarbamol to Oxybutynin for Stent ColicAUA 2024 efficacy of methocarbamol versus oxybutynin for alleviating stent colic, management of nephrolithiasis and retrograde intrarenal ...
MP04-12RESULTS: 60 patients were recruited with 30 randomized to receive methocarbamol and 30 to receive oxybutynin postoperatively. Patients had a comparable stone ...
mp04-12 comparing methocarbamol to oxybutynin for stent ...There were no significant differences in utilization of methocarbamol versus oxybutynin for management of postoperative stent colic following ...
Methocarbamol - StatPearls - NCBI BookshelfMethocarbamol is an anti-spasmodic agent used to treat involuntary skeletal muscle spasms, differentiating it from anti-spastic agents like dantrolene and ...
Methocarbamol (oral route) - Side effects & dosageKidney disease or; Liver disease—Use with caution. The effects of this medicine may be increased because of slower removal from the body.
Methocarbamol: Uses, Interactions, Mechanism of ActionOverdose of methocarbamol may be associated with alcohol and other central nervous system depressants. Patients may experience nausea, drowsiness, blurred ...
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