Actively Recruiting
Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Led by Mayo Clinic · Updated on 2025-05-13
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether intravenous magnesium can help treat bladder spasms that occur after urologic surgery. This Phase 2 clinical trial compares magnesium infusion to a placebo in adults undergoing bladder invasive procedures, aiming to better understand its impact on post-operative bladder spasms. Participants will be randomly assigned to receive either an intravenous magnesium infusion or an equivalent volume of normal saline (placebo) during their urologic surgery. The magnesium dose includes a loading infusion of 50 mg/Kg followed by 15 mg/Kg per hour. The study is quadruple-masked to keep participants and researchers unaware of the assigned treatment during the surgery. During the study, researchers will monitor the incidence and severity of bladder spasms approximately 1 and 4 hours after surgery. They will also assess treatments used for spasms and patient satisfaction about 4 hours post-operation. The trial involves outpatient procedures and aims to complete by the end of 2026, with careful safety and effectiveness monitoring throughout.
CONDITIONS
Brief Title
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.
You will not qualify if you...
- Unable to grant informed consent or comply with study procedures.
- Allergy or known sensitivity to magnesium or Renacidin.
- Expected or high risk of bladder extravasation.
- Ongoing atrial fibrillation prior to surgery.
- Undergoing emergency surgery.
- Pregnant.
- Known hypermagnesemia.
- Neuromuscular weakness (e.g., Myasthenia gravis).
- Myocardial compromise or cardiac conduction defects.
- Renal insufficiency with glomerular filtration rate less than 30.
- Concomitant use of a calcium channel blocker due to potential muscle weakening effects with magnesium sulfate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive intravenous magnesium or placebo during their urologic surgery as part of standard care.
1 surgical visit (in-person)
Duration - Up to approximately 4 hours post-surgery
Participants are monitored for bladder spasms and related outcomes after surgery.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
T
Tami Krpata
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Frequently Asked Questions
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