A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

NCT05806996 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-006895
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Spasms

Outcome Measures

Primary Outcomes (1)

• Incidence of bladder spasm

  Number of subjects to experience bladder spasms

  Post-operative, approximately 1 hour

Secondary Outcomes (3)

• Incidence of bladder spasm above moderate grade

  Post-operative, approximately 4 hours

• Treatment for bladder spasms

  Post-operative, approximately 4 hours

• Patient satisfaction

  Post-operative, approximately 4 hours

Study Arms (2)

Magnesium Group

EXPERIMENTAL

Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.

Drug: Magnesium

Placebo Group

PLACEBO COMPARATOR

Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.

Drug: Placebo

Interventions

Magnesium DRUG

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

Magnesium Group

Placebo DRUG

Equivalent volume of normal saline

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Gregory Nuttall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tami Krpata

CONTACT

507-422-5768; krpata.tami@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 10, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)