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Prophylactic Antibiotics Before Botox Injections for Antibiotic Prophylaxis
Phase 4
Recruiting
Led By Carolyn Botros, DO
Research Sponsored by Atlantic Health System
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 6 weeks
Awards & highlights
Study Summary
This trial aims to show that not giving antibiotics to people before they have a Botox injection in their bladder is not worse than giving them antibiotics. This could help decrease the use of antibiotics overall to help with antibiotic resistance.
Who is the study for?
This trial is for women aged 18 or older who are undergoing bladder Botox treatments. They must be able to take oral medication and not have allergies to antibiotics or Botox components. Participants should not have urinary retention issues, be pregnant, or breastfeeding.Check my eligibility
What is being tested?
The study compares the effect of taking Nitrofurantoin antibiotics before and after bladder Botox injections versus no antibiotic use at all. The goal is to see if skipping antibiotics doesn't increase UTI risk, which could help fight antibiotic resistance.See study design
What are the potential side effects?
Potential side effects from Nitrofurantoin may include digestive upset, headache, dizziness, and lung problems. Allergic reactions can occur but only participants without known hypersensitivity will be included.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Urinary tract infections
Other outcome measures
Urinary retention and adverse reactions
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Antibiotic armExperimental Treatment1 Intervention
Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.
Group II: No treatment armActive Control1 Intervention
No antibiotics administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrofurantoin
2011
Completed Phase 4
~3720
Find a Location
Who is running the clinical trial?
Atlantic Health SystemLead Sponsor
52 Previous Clinical Trials
6,147 Total Patients Enrolled
Columbia UniversityOTHER
1,433 Previous Clinical Trials
2,447,119 Total Patients Enrolled
Carolyn Botros, DOPrincipal InvestigatorAtlantic Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I cannot take medication orally.I am female.I am receiving Botox treatment for my bladder.I am not allergic to Botox and can use a catheter if needed after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: No treatment arm
- Group 2: Antibiotic arm
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
Are there any spots still available for potential participants in this medical trial?
"Clinicaltrials.gov confirms that this clinical trial is presently enrolment patients and has been open since 8/16/2022, with the last update taking place on 8/25/2022."
Answered by AI
How many participants are currently enrolled in this trial?
"Affirmative, the information posted on clinicaltrials.gov confirms that this medical experiment is actively seeking volunteers. It was initially advertised on August 16th 2022 and has been recently updated on August 25th 2022. Recruitment for 140 participants is currently underway at a single location."
Answered by AI
Has Nitrofurantoin been authorized by the FDA for use?
"Nitrofurantoin is deemed safe with a score of 3, due to the final phase 4 clinical trials which have approved this drug."
Answered by AI
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