Magnesium for Bladder Spasms

Overseen By Tami Krpata

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Calcium channel blockers

Disqualifiers: Atrial fibrillation, Pregnancy, Renal insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether intravenous magnesium can reduce bladder spasms after urologic surgery. Participants will receive either magnesium (a mineral supplement) or a placebo (a harmless substance with no treatment effect) during their surgery. The trial is best suited for those undergoing a bladder procedure at the Mayo Clinic's Gonda 7 Outpatient Procedure Center. Individuals with conditions such as ongoing heart rhythm issues, kidney problems, or muscle weakness might not qualify. The researchers aim to determine if magnesium eases spasms, making recovery more comfortable. As a Phase 2 trial, this research measures magnesium's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking a calcium channel blocker, you may not be eligible to participate.

Is there any evidence suggesting that intravenous magnesium is likely to be safe for humans?

Research has shown that magnesium is generally safe for treating bladder spasms. In previous studies, patients who took magnesium experienced less bladder discomfort after surgery. For instance, one study found that magnesium reduced catheter-related issues and increased patient satisfaction. Another study demonstrated that using magnesium during surgery did not lead to additional complications in common bladder surgeries. This suggests magnesium is safe in these situations. Although not yet officially approved for bladder spasms, its use in other medical areas supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about magnesium for bladder spasms because it offers a new approach by using magnesium's muscle-relaxing properties to target the spasms directly. Unlike standard treatments like anticholinergics or muscle relaxants, which can have systemic side effects, magnesium is introduced intravenously during surgery for a more targeted effect. This method could potentially reduce side effects and improve recovery times, making it a promising alternative for patients undergoing urological surgery.

What evidence suggests that magnesium might be an effective treatment for bladder spasms?

Research has shown that magnesium might help ease bladder spasms after urologic surgery. One study found that patients who took magnesium experienced less bladder discomfort from catheters. Another study discovered that magnesium reduced bladder spasms. In this trial, participants in the Magnesium Group will receive intravenous magnesium during surgery to evaluate its effectiveness. These findings suggest that magnesium could be a promising treatment for bladder problems after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Gregory Nuttall, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals undergoing bladder procedures at Mayo Clinic Gonda 7 Outpatient Center, who are not pregnant, don't have severe kidney issues or a high magnesium level, can consent to the study, and aren't allergic to magnesium. People with muscle weakness conditions like Myasthenia gravis, those on calcium channel blockers, with ongoing atrial fibrillation or heart problems should not participate.

Inclusion Criteria

Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.

Exclusion Criteria

Are undergoing emergency surgery.

You have high levels of magnesium in your blood.

You have kidney problems with a very low glomerular filtration rate, which could cause magnesium levels in your blood to increase too much.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intravenous magnesium or placebo during urologic surgery

During surgery

Post-operative Monitoring

Participants are monitored for bladder spasms and patient satisfaction post-surgery

4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium
• Placebo

Trial Overview The study is testing if giving magnesium through an IV can help prevent bladder spasms after urologic surgeries compared to a placebo. Participants will be randomly assigned to receive either magnesium or a placebo during their procedure.

How Is the Trial Designed?

Group I: Magnesium Group Experimental Treatment 1 Intervention

Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.

Group II: Placebo Group Placebo Group 1 Intervention

Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.

Magnesium is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Approved in European Union as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Approved in Canada as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The compounds synthesized, including [Mg{In(SC{O}Ph)4}2] and [Ca(H2O)x{In(SC{O}Ph)4}2], were characterized using X-ray crystallography, revealing distinct structural features such as distorted octahedral coordination around Mg(II) and Ca(II) ions.

Thermal decomposition of these compounds leads to the formation of MIn2S4 materials, which was confirmed through X-ray powder diffraction, indicating potential applications in materials science.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Syntheses and structures of [M{In(SC{O}Ph)4}2] (M = Mg and Ca): single molecular precursors to MIn2S4 materials. Tian, L., Lye, WH., Deivaraj, TC., et al.[2006]

The novel boron-centered non-nucleophilic electrolyte (BMCM) for magnesium batteries shows excellent electrochemical performance, including a low overpotential of approximately 139 mV and a high Coulombic efficiency of about 97%.

BMCM demonstrates long-term cycling stability of over 500 hours and good compatibility with CuS cathodes, making it a promising and cost-effective option for the commercialization of rechargeable magnesium batteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facile and Economic Synthesis of Robust Non-Nucleophilic Electrolyte for High-Performance Rechargeable Magnesium Batteries. Huang, X., Wen, J., Lei, J., et al.[2022]

The novel Mg[Al(hfip)4]2 salt shows high tolerance to water and benefits from additives, making it a promising candidate for stable and efficient magnesium battery electrolytes.

When tested with various magnesium cathodes, the Mg[Al(hfip)4]2-based electrolytes outperformed those with the traditional Mg[B(hfip)4]2 salt, suggesting it could set a new standard for future magnesium battery research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Practical Applications of the Magnesium Fluorinated Alkoxyaluminate Electrolyte in Mg Battery Cells. Pavčnik, T., Lozinšek, M., Pirnat, K., et al.[2022]

In a study involving 7 normal subjects and 4 patients with recurrent calcium oxalate kidney stones, magnesium citrate and magnesium oxide increased urinary magnesium and citrate levels, but only when taken with meals, leading to a decrease in urinary oxalate and improved urinary saturation of calcium oxalate.

The findings suggest that for magnesium supplements to effectively help manage recurrent calcium oxalate nephrolithiasis, they should be taken with meals to enhance their efficacy in reducing stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of magnesium citrate and magnesium oxide on the crystallization of calcium salts in urine: changes produced by food-magnesium interaction. Lindberg, J., Harvey, J., Pak, CY.[2019]

A 51-year-old man with variant angina showed significant coronary arterial spasm that was not relieved by traditional treatments like calcium blockers and nitrates.

After receiving an hourly infusion of magnesium sulfate, the patient's coronary spasm could not be induced, suggesting that magnesium supplementation may be an effective treatment for variant angina related to magnesium deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variant angina due to deficiency of intracellular magnesium. Tanabe, K., Noda, K., Kamegai, M., et al.[2020]

In a study of 90 patients with acute renal colic, magnesium sulfate was found to be a safe adjunct treatment for pain control, showing similar effectiveness to morphine in reducing pain scores over time.

While both magnesium sulfate and morphine achieved a high success rate in pain reduction, morphine provided quicker relief, with more patients being pain-free at the 20-minute mark, although both treatments were equally effective by 30 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Magnesium Sulfate for Pain Management in Patients with Acute Renal Colic; a Randomized Clinical Trial. Majidi, A., Derakhshani, F.[2022]

The compound 2C(6)H(9)N(2)(+)·SO(4)(2-)·H(2)O consists of two isomeric protonated amino-methyl-pyridine cations, a sulfate anion, and a water molecule, indicating a complex molecular structure.

The crystal structure is stabilized by various interactions, including hydrogen bonds and π-π stacking, which contribute to a robust three-dimensional network, suggesting potential applications in materials science or pharmaceuticals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-Amino-3-methyl-pyridinium 2-amino-5-methyl-pyridinium sulfate monohydrate. Gong, J., Chen, G., Ni, SF., et al.[2021]

In a double-blind clinical trial involving patients with renal colic pain, magnesium sulphate did not provide significant pain relief compared to a control group receiving only Ketorolac.

Both treatment groups experienced a reduction in pain after 30 minutes, but there were no statistically significant differences in pain scores between the magnesium sulphate group and the control group at 15 or 30 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison the analgesic effect of magnesium sulphate and Ketorolac in the treatment of renal colic patients: Double-blind clinical trial study. Maleki Verki, M., Porozan, S., Motamed, H., et al.[2020]

In a study of 120 patients undergoing transurethral resection of bladder tumor, intravenous magnesium significantly reduced the incidence of moderate-to-severe catheter-related bladder discomfort immediately after surgery (22% in the magnesium group vs. 77% in the control group).

Patients receiving magnesium also reported higher satisfaction levels postoperatively, indicating that magnesium not only alleviates discomfort but also enhances the overall patient experience without increasing adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium and Bladder Discomfort after Transurethral Resection of Bladder Tumor: A Randomized, Double-blind, Placebo-controlled Study. Park, JY., Hong, JH., Kim, DH., et al.[2020]

The compound [NH(3)(CH(2))(2)NH(3)][Mg(SO(4))(2)(H(2)O)(4)] was successfully synthesized using a slow evaporation method, indicating a reliable approach for creating this specific crystal structure.

The crystal structure features a unique arrangement of inorganic magnesium sulfate anions and organic ammonium cations, held together by hydrogen bonds, which may have implications for its potential applications in materials science.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethyl-enediammonium tetraaquadi-sulfatomagnesium(II). Rekik, W., Naïli, H., Mhiri, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05806996

A Study of Magnesium and Bladder Spasms Following ... This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery. Official Title.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380422/

Intraoperative magnesium sulfate is not associated with ... Patients in the intervention group received an average of 4.1 ± 0.6g of magnesium sulfate. The study demonstrated that patients who received Mg ...

3. med.virginia.edu med.virginia.edu/urology/wp-content/uploads/sites/248/2021/02/Magnesium-for-bladder-spasm_Park-2020.pdf

Magnesium-for-bladder-spasm_Park-2020.pdf In this study, we found that magnesium administration sig- nificantly decreased the incidence of catheter-related blad- der discomfort above a ...

4. trialx.com trialx.com/clinical-trials/listings/246831/a-study-of-magnesium-and-bladder-spasms-following-ambulatory-urologic-procedures/?&radius=10&place=A&user_country=Concord%20N

A Study of Magnesium and Bladder Spasms Following ... This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.

5. mayo.edu mayo.edu/research/clinical-trials/cls-20547956

A Study of Magnesium and Bladder Spasms Following ... The purpose of this study is to to perform a trial of magnesium infusion to prevent bladder spasms.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32304405/

Magnesium and Bladder Discomfort after Transurethral ... Conclusions: Magnesium reduced the incidence of catheter-related bladder discomfort above a moderate grade and increased patient satisfaction among patients ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38042781/

Effect of magnesium sulfate perioperative infusion on ... The primary outcome was the incidence of CRBD at 0 h after the surgery. The secondary outcomes included incidence of CRBD at 1, 2, and 6 h ...

8. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-024-00448-x

Intraoperative magnesium sulfate is not associated with ... In that context, this study aims to evaluate the use of magnesium in common urologic surgeries including robot-assisted radical prostatectomy ( ...