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Recruiting

NCT Number: NCT05806996

A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

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

Recruiting

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Key information

Conditions

Bladder Spasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Holly Carlson

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium

Drug

Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour

Placebo

Drug

Equivalent volume of normal saline

Primary outcomes

  1. Incidence of bladder spasm

    Time frame: Post-operative, approximately 1 hour

    Number of subjects to experience bladder spasms

Secondary outcomes

  1. Incidence of bladder spasm above moderate grade

    Time frame: Post-operative, approximately 4 hours

    Number of subjects to experience bladder spasms above moderate grade

  2. Treatment for bladder spasms

    Time frame: Post-operative, approximately 4 hours

    Number of subjects requiring treatment for bladder spasms

  3. Patient satisfaction

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tami Krpata

CONTACT

[email protected]

507-422-5768

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.