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2: Multi-Dose Antibiotic Prophylaxis for Overactive Bladder

Phase 4

Waitlist Available

Led By Emily Slopnick, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will compare single-dose vs multi-day antibiotic prophylaxis before bladder onabotulinumtoxinA injection to see if it affects UTI risk.

Eligible Conditions

Overactive Bladder
Urge Incontinence
Urge Urinary Incontinence

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration.

Secondary outcome measures

Antibiotic Adverse Events

Symptomatic Urinary Retention

Trial Design

2Treatment groups

Active Control

Group I: 2: Multi-Dose Antibiotic ProphylaxisActive Control1 Intervention

Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy.

Group II: 1: Single-Dose Antibiotic ProphylaxisActive Control1 Intervention

Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,363,918 Total Patients Enrolled

Emily Slopnick, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed single-dose antibiotic prophylaxis?

"We gave 1: Single-Dose Antibiotic Prophylaxis a score of 3 since it is an approved Phase 4 medication, implying that there are multiple levels of clinical evidence substantiating its safety."

Answered by AI

Is the enrollment period for this medical experiment still open?

"Contrary to what is stated on clinicaltrials.gov, this particular medical trial does not currently have any open recruitment slots for participants. It was initially posted back in December of 2022 and last updated January 31st 2023; however, there are other 193 experiments looking for volunteers at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

2022. "Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05719285.