Back to resultsA Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Primary Purpose
Bladder Spasms
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnesium
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Spasms
Eligibility Criteria
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 unable to grant informed consent or comply with study procedure. Allergy or known sensitivity to magnesium or Renacidin. Expected or high risk of bladder extravasation. Ongoing atrial fibrillation prior to surgery. Are undergoing emergency surgery. Are pregnant. Known hypermagnesemia. Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect. Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects. Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium. Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.
Sites / Locations
- Mayo Clinic in MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium Group
Placebo Group
Arm Description
Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.
Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.
Outcomes
Primary Outcome Measures
Incidence of bladder spasm
Number of subjects to experience bladder spasms
Secondary Outcome Measures
Incidence of bladder spasm above moderate grade
Number of subjects to experience bladder spasms above moderate grade
Treatment for bladder spasms
Number of subjects requiring treatment for bladder spasms
Patient satisfaction
Assessed using a seven-point Likert scale where 1=strongly dissatisfied, 2=moderately dissatisfied, 3=slightly dissatisfied, 4=neutral, 5=slightly satisfied, 6=moderately satisfied, 7=extremely satisfied
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05806996
Brief Title
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Official Title
Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Spasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Group
Arm Type
Experimental
Arm Description
Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Equivalent volume of normal saline
Primary Outcome Measure Information:
Title
Incidence of bladder spasm
Description
Number of subjects to experience bladder spasms
Time Frame
Post-operative, approximately 1 hour
Secondary Outcome Measure Information:
Title
Incidence of bladder spasm above moderate grade
Description
Number of subjects to experience bladder spasms above moderate grade
Time Frame
Post-operative, approximately 4 hours
Title
Treatment for bladder spasms
Description
Number of subjects requiring treatment for bladder spasms
Time Frame
Post-operative, approximately 4 hours
Title
Patient satisfaction
Description
Assessed using a seven-point Likert scale where 1=strongly dissatisfied, 2=moderately dissatisfied, 3=slightly dissatisfied, 4=neutral, 5=slightly satisfied, 6=moderately satisfied, 7=extremely satisfied
Time Frame
Post-operative, approximately 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 unable to grant informed consent or comply with study procedure.
Allergy or known sensitivity to magnesium or Renacidin.
Expected or high risk of bladder extravasation.
Ongoing atrial fibrillation prior to surgery.
Are undergoing emergency surgery.
Are pregnant.
Known hypermagnesemia.
Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Carlson
Phone
507-422-5102
Email
Gebel.Holly@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Nuttall, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Carlson
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
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