A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Phase 2

Recruiting

• Conditions: Bladder Spasms
• Interventions: Drug: Placebo; Drug: Magnesium

• Registration Number: NCT05806996
• Lead Sponsor: Mayo Clinic

Brief Summary

This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-10
• Study Start: 2023-07-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.
Magnesium Group	Magnesium	Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of bladder spasm	Post-operative, approximately 1 hour	Number of subjects to experience bladder spasms

Secondary Outcome Measures

Name	Time	Method
Incidence of bladder spasm above moderate grade	Post-operative, approximately 4 hours	Number of subjects to experience bladder spasms above moderate grade
Treatment for bladder spasms	Post-operative, approximately 4 hours	Number of subjects requiring treatment for bladder spasms
Patient satisfaction	Post-operative, approximately 4 hours	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

Trial Locations

Locations (1)

Mayo Clinic in Minnesota; 🇺🇸 Rochester, Minnesota, United States