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Procedure
Antibiotic Usage for Overactive Bladder
N/A
Recruiting
Led By Kathleen Kobashi, 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
Study Summary
This trial is testing whether it's necessary to give patients antibiotics before a procedure to treat overactive bladder.
Eligible Conditions
- Overactive Bladder
- Urinary Tract Infection
- Antibiotic Stewardship
- Botox
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary tract infection
Secondary outcome measures
Percentage of subjective improvement in overactive bladder symptoms
Rate of adverse events including dysuria, gross hematuria, and urinary retention
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.
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Who is running the clinical trial?
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)UNKNOWN
Stony Brook UniversityOTHER
213 Previous Clinical Trials
39,327 Total Patients Enrolled
Northwell HealthOTHER
458 Previous Clinical Trials
470,733 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of this clinical trial in terms of participant numbers?
"Yes, the official records on clinicaltrials.gov specify that this study is actively recruiting for participants. The initial posting was made on March 23rd 2021 and it has been recently refreshed on July 21st 2022. 200 volunteers are needed from 1 site to fill out the trial's requirements."
Answered by AI
Are there any vacancies available in this clinical research project?
"Affirmative. Clinicaltrials.gov demonstrates that sign-up for this medical trial commenced on March 23rd 2021 and the post was last amended on July 21st 2022. The research is searching for 200 candidates to be drawn from 1 location."
Answered by AI
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