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Procedure
Antibiotic Usage for Overactive Bladder
N/A
Recruiting
Led By Justina Tam, MD
Research Sponsored by Benaroya Research Institute
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 14-30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether it's necessary to give patients antibiotics before a procedure to treat overactive bladder.
Who is the study for?
Adults over 18 with an overactive bladder (OAB) who haven't improved with first and second-line treatments can join. They must not show symptoms or test positive for a urinary tract infection (UTI) at the time of treatment. Pregnant or breastfeeding women, recent antibiotic users, and those treated with high doses of onabotulinumtoxinA are excluded.
What is being tested?
The study is testing if giving antibiotics before injecting onabotulinumtoxinA into the bladder helps prevent UTIs in OAB patients without current infections. Participants will either receive a prophylactic antibiotic or no antibiotic before the procedure, to see which approach is better.
What are the potential side effects?
Potential side effects include complications from taking antibiotics like diarrhea that could lead to severe conditions, increased drug resistance, skin allergies, and stomach issues. The injection may also cause UTIs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14-30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14-30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Urinary tract infection
Secondary study objectives
Percentage of subjective improvement in overactive bladder symptoms
Rate of adverse events including dysuria, gross hematuria, and urinary retention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Prophylactic antibioticExperimental Treatment2 Interventions
These patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities.
Group II: No antibioticsExperimental Treatment2 Interventions
These patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy.
Find a Location
Who is running the clinical trial?
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)UNKNOWN
Stony Brook UniversityOTHER
223 Previous Clinical Trials
41,352 Total Patients Enrolled
Northwell HealthOTHER
475 Previous Clinical Trials
469,084 Total Patients Enrolled
Virginia Mason Hospital/Medical CenterOTHER
22 Previous Clinical Trials
8,323 Total Patients Enrolled
Benaroya Research InstituteLead Sponsor
49 Previous Clinical Trials
12,057 Total Patients Enrolled
Justina Tam, MDPrincipal InvestigatorStony Brook Medicine
Kathleen Kobashi, MDPrincipal InvestigatorVirginia Mason Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken antibiotics in the 48 hours before getting an injection of onabotulinumtoxinA into the bladder.You do not have symptoms of a urinary tract infection when you receive the injection.You have received more than 400 units of onabotulinumtoxinA injections within a 3-month period.Your urine test should not show signs of infection, and the number of white blood cells should be low.You have been diagnosed with OAB and have tried the first and second recommended treatments without success.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic antibiotic
- Group 2: No antibiotics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.