Methocarbamol vs Oxybutynin for Pain After Kidney Stone Procedure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Methocarbamol vs Oxybutynin for Pain After Kidney Stone Procedure is an effective drug?

The available research does not provide specific data on the effectiveness of Methocarbamol or Oxybutynin for pain after a kidney stone procedure. Instead, it discusses other drugs and treatments like NSAIDs, opioids, and α-blockers, which are commonly used for pain relief and stone expulsion. For example, α-blockers have been shown to help with stone clearance and reduce pain intensity. However, there is no direct comparison or evidence provided for Methocarbamol or Oxybutynin in this context. ^{1 2 3 4 5}

What safety data is available for Methocarbamol and Oxybutynin in treating pain after kidney stone procedures?

For Oxybutynin (Ditropan), studies show it is effective in controlling post-transurethral pain and spasm with no significant side effects noted in one trial. However, it can cause atropinic and allergic reactions, especially in children. It has been used effectively for bladder spasm and neurogenic bladder, with oral dryness as a tolerable side effect. No specific safety data for Methocarbamol (Robaxin) in this context is provided in the research. ^{6 7 8 9 10}

Is the drug used in the trial 'Methocarbamol vs Oxybutynin for Pain After Kidney Stone Procedure' a promising treatment?

The information provided does not mention methocarbamol or oxybutynin, so we cannot determine if they are promising treatments for pain after a kidney stone procedure based on this data. ^{1 2 11 12 13}

Research Team

Eligibility Criteria

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

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

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.

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

Treatment Details

Interventions

• Methocarbamol (Muscle Relaxant)
• Oxybutynin (Anticholinergic)

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.

Participant Groups

Group I: Methocarbamol Active Control 1 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: Oxybutynin Active Control 1 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).

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

In a study involving 1167 adults with ureteric colic, treatment with tamsulosin or nifedipine did not significantly increase the rate of spontaneous stone passage compared to placebo, indicating that these muscle relaxants may not be effective for this condition.

The use of tamsulosin and nifedipine was also found to be unlikely to be cost-effective for the NHS, as there was no significant difference in quality-adjusted life years (QALYs) gained between the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-controlled, randomised controlled trial and cost-effectiveness analysis of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the SUSPEND trial). Pickard, R., Starr, K., MacLennan, G., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 47 patients with acute renal colic, tenoxicam (20 mg i.v.) provided significant pain relief to 80% of patients within one hour, compared to 72.7% for buscopan compositum, indicating its superior efficacy.

Unlike buscopan compositum, which led to a 62% relapse in pain requiring additional treatment, none of the patients treated with tenoxicam experienced a relapse, and no side effects were reported, highlighting its safety and prolonged analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous tenoxicam to treat acute renal colic: comparison with buscopan compositum. al-Waili, NS., Saloom, KY.[2016]

In a double-blind trial, oxybutynin chloride (Ditropan) was effective in controlling post-transurethral pain and spasm, indicating its potential as a treatment option for patients experiencing these symptoms.

The study reported no significant side effects associated with oxybutynin chloride, suggesting it is a safe option for managing post-procedural discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxybutynin chloride in control of post-trasurethral vesical pain and spasm. Paulson, DF.[2019]

Oxybutynin chloride is effective in managing conditions like neurovesical dysfunction, enuresis, and bladder spasms due to its anticholinergic and muscle relaxant properties, as shown in controlled clinical studies.

The drug's synergistic effects on both the nervous system and muscle relaxation make it a valuable treatment option for patients with uninhibited bladders and primary muscle spasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. Thompson, IM., Lauvetz, R.[2019]

In a study involving 25 patients with idiopathic hyperactive bladder function, Ditropan (oxybutynin chloride) significantly reduced voiding frequency and eliminated urgency, indicating its efficacy in managing bladder overactivity.

Control cystometry showed a significant increase in bladder capacity after treatment, while oral dryness was reported as a tolerable side effect, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idiopathic bladder hyperactivity treated with Ditropan (oxybutynin chloride). Nagy, F., Hamvas, A., Frang, D.[2019]

Current pain management in shockwave lithotripsy (SWL) lacks standardized protocols, but general and spinal anesthesia provide excellent pain control for select cases.

Newer analgesics, including nitrous oxide and refined local anesthesia techniques, show promising effectiveness and favorable side effects, making them viable options for pain control during SWL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs for pain management in shock wave lithotripsy. Bach, C., Zaman, F., Kachrilas, S., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pain killers and antibacterial therapy for kidney colic and stones. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Medical Expulsive Therapy (MET) in Improving Stone-free Rate and Stone Expulsion Time, After Extracorporeal Shock Wave Lithotripsy (SWL) for Upper Urinary Stones: A Systematic Review and Meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-controlled, randomised controlled trial and cost-effectiveness analysis of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the SUSPEND trial). [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the efficacy of isosorbide-SR addition to current treatment in medical expulsive therapy for ureteral calculi. [2021]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Intravenous tenoxicam to treat acute renal colic: comparison with buscopan compositum. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Oxybutynin chloride in control of post-trasurethral vesical pain and spasm. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Idiopathic bladder hyperactivity treated with Ditropan (oxybutynin chloride). [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Drugs for pain management in shock wave lithotripsy. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

A comparison of efficacy of doxazosin 4 and 8 mg in medical expulsive therapy of distal ureteral stones: a prospective randomized clinical trial. [2018]

13. England pubmed.ncbi.nlm.nih.gov

A network meta-analysis on the beneficial effect of medical expulsive therapy after extracorporeal shock wave lithotripsy. [2019]