A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
ConditionBladder Spasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium
DrugIntravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour
Placebo
DrugEquivalent volume of normal saline
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Magnesium GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of bladder spasm
Number of subjects to experience bladder spasms
Time frame
Post-operative, approximately 1 hourSecondary outcomes
1
Incidence of bladder spasm above moderate grade
Number of subjects to experience bladder spasms above moderate grade
Time frame
Post-operative, approximately 4 hours2
Treatment for bladder spasms
Number of subjects requiring treatment for bladder spasms
Time frame
Post-operative, approximately 4 hours3
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
Time frame
Post-operative, approximately 4 hoursSponsors and contacts
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Source ClinicalTrials.gov