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Electrolyte Supplement
Magnesium for Bladder Spasms
Phase 2
Recruiting
Led By Gregory Nuttall, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative, approximately 4 hours
Awards & highlights
Study Summary
This trial is testing if magnesium can reduce bladder spasms after urological surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of intravenous magnesium may include feelings of warmth or flushing, nausea and vomiting, drowsiness, muscle weakness, irregular heartbeat in susceptible individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative, approximately 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative, approximately 4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of bladder spasm
Secondary outcome measures
Incidence of bladder spasm above moderate grade
Patient satisfaction
Treatment for bladder spasms
Side effects data
From 2013 Phase 3 trial • 38 Patients • NCT012738838%
Loose Stool
8%
Diarrhea
3%
Headache
3%
Emergency Room Visit
3%
Intermittent Ankle Swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magnesium
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium GroupExperimental Treatment1 Intervention
Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium
2010
Completed Phase 4
~2980
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,368 Total Patients Enrolled
Gregory Nuttall, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
1,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.There is a high chance that the study drug may leak into the bladder.You have a condition that weakens your muscles, like Myasthenia gravis, that could be made worse by the muscle-weakening effects of magnesium.You are taking a calcium channel blocker along with magnesium sulfate, which could make your muscles not work properly.You have atrial fibrillation that is currently happening before the surgery.You have heart problems that could be made worse by the effects of magnesium.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: Magnesium Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How secure is the usage of Magnesium Group in patients?
"Magnesium Group's safety was scored a 2, as there is evidence of its security but not yet any verifiable proof of efficacy."
Answered by AI
Are new applicants being accepted for this experiment currently?
"Regrettably, the information on clinicaltrials.gov states this trial is no longer enrolling patients; it was initially posted to the database in April of 2023 and updated for the last time in March of that same year. However, 12 other studies are currently looking for recruits at present."
Answered by AI
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