Bladder SpasmsPhase 2NCT05806996
A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
A Phase 2 study testing Magnesium in people with Bladder Spasms, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Spasms
- What is being tested?
- Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Bladder Spasms
- Being tested
- Magnesium, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour
PlaceboDrug
Equivalent volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Group | Experimental | Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery. Receives: Drug: Magnesium |
| Placebo Group | Placebo comparator | Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bladder spasm
Number of subjects to experience bladder spasms
Measured: Post-operative, approximately 1 hour
Secondary outcomes (3)
Incidence of bladder spasm above moderate grade
Number of subjects to experience bladder spasms above moderate grade
Measured: Post-operative, approximately 4 hours
Treatment for bladder spasms
Number of subjects requiring treatment for bladder spasms
Measured: Post-operative, approximately 4 hours
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
Measured: Post-operative, approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start30 Jun 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder SpasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A Nuttall, Mayo Clinic
- Investigators
- Gregory Nuttall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806996
- Sponsor's protocol ID
- 22-006895
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
- ClinicalTrials.gov ID
- NCT05806996
- Acronym / sponsor ID
- 22-006895
- Conditions
- Bladder Spasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Group | Experimental | Drug: MagnesiumSubjects having urology surgery per standard of care will receive intravenous magnesium during the surgery. |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects having urology surgery per standard of care will receive intravenous placebo during the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnesiumIntravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour | Drug | Magnesium Group |
| PlaceboEquivalent volume of normal saline | Drug | Placebo Group |
Primary outcome
Incidence of bladder spasm
Time frame: Post-operative, approximately 1 hour
Number of subjects to experience bladder spasms
3 secondary outcomes
Incidence of bladder spasm above moderate grade
Time frame: Post-operative, approximately 4 hours
Treatment for bladder spasms
Time frame: Post-operative, approximately 4 hours
Patient satisfaction
Time frame: Post-operative, approximately 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Nuttall, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium in people with Bladder Spasms, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bladder spasm (time frame: Post-operative, approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.