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Anti-bacterial
Prophylactic Antibiotics for Urinary Incontinence
Phase 4
Waitlist Available
Led By Susanne Taege, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant)
Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST)
Must not have
Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly
Pelvic organ prolapse stage greater than 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after the procedure
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to see if giving patients oral antibiotics before a certain procedure can lower the chances of getting a urinary tract infection afterwards. They also want to look at the rates of urinary tract infections and success
Who is the study for?
This trial is for individuals planning to undergo Bulkamid treatment for stress urinary incontinence or mixed urinary incontinence at The Ohio State University. Participants must not have recurrent UTIs, be on daily antibiotics, pregnant, have significant pelvic organ prolapse or immunosuppression, and should not have taken recent antibiotics.
What is being tested?
The study aims to determine if prophylactic oral antibiotics reduce the risk of UTI after Bulkamid urethral bulking. It compares the effectiveness of a placebo with Bactrim or Macrobid and looks at UTI rates with different catheterization methods post-surgery.
What are the potential side effects?
Possible side effects may include typical reactions to antibiotics such as stomach upset, diarrhea, rash, and rarely more severe allergic reactions. There's also a potential increased risk of developing antibiotic resistance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am seeing a specialist for urinary incontinence and plan to have a Bulkamid treatment.
Select...
I have been diagnosed with stress urinary incontinence.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am having other pelvic or urologic surgeries along with my main procedure.
Select...
My pelvic organ prolapse is more severe than stage 2.
Select...
I cannot take oral antibiotics due to allergies or kidney problems.
Select...
I have had 3 or more UTIs in the last year or 2 in the last 6 months.
Select...
I am currently on daily antibiotics for prevention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after the procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Risk of post operative urinary tract infections (UTI)
Secondary study objectives
Drug Use and Side Effects
Effects on higher patient satisfaction
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Bactrim or Macrobid (single dose)Active Control1 Intervention
Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies
Group II: PlaceboPlacebo Group1 Intervention
Identical appearing placebo for a single dose
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,594 Total Patients Enrolled
Susanne Taege, MDPrincipal InvestigatorOhio State University