Antibiotic Prophylaxis for Neurogenic Bladder Botox

Launched by UNIVERSITY OF ALBERTA · Mar 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether giving antibiotics at the same time as Botox injections for the bladder can help prevent infections after the procedure. Botox is used to treat neurogenic bladder, which is when the bladder doesn’t work properly due to a neurological condition. Unfortunately, some patients develop urinary tract infections (UTIs) after receiving Botox, and researchers want to find out if taking antibiotics beforehand can help reduce this risk. In this study, participants will be randomly assigned to receive either antibiotics or a placebo (a pill with no active ingredients) after their Botox treatment.

To be eligible for this trial, participants should be at least 18 years old and have neurogenic overactive bladder caused by conditions like multiple sclerosis or spinal cord injury. They should also be able to understand and speak English and not have any current infections or allergies that would prevent them from receiving the treatments. Participants in the study can expect to be closely monitored to see if the antibiotics help in reducing post-operative infections, which could lead to better outcomes for future patients and help in managing antibiotic use in healthcare.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants with neurogenic OAB, defined as OAB associated with a neurologic condition such as multiple sclerosis, Parkinson's disease, spinal cord injury, previous stroke, or any other neurologic condition the participant may have been told is a cause of their OAB symptoms
• • 2. Age ≥ 18
• • 3. Participants must be able to read, speak, and write in English
• • 4. No contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR \> 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
• • 5. No contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
• • 6. No active antibiotic therapy for any indication at the time of Botox injection
• • 7. Not pregnant and/or breastfeeding - Botox is contraindicated in pregnancy (screen serum pregnancy test 72 hrs prior to the procedure is standard of care).
• • 8. No active symptomatic UTI the day of the procedure - wherein the participant presents the day of their Botox procedure with new or worsening urinary frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for exclusion from the study - bladder Botox is contraindicated in patients with active symptomatic UTI
• Exclusion Criteria:
• • 1. Participants with idiopathic OAB
• • 2. Age \< 18
• • 3. Patients who cannot read, speak, and write in English
• • 4. Any contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR \> 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
• • 5. Any contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
• • 6. Active antibiotic therapy for any indication at the time of Botox injection
• • 7. Pregnant (as indicated by pre-operative serum quantitative B-hCG for patients aged 18 to 51 without previous hysterectomy) and/or breastfeeding
• • 8. Active symptomatic UTI the day of the procedure - wherein the participant presents with new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for exclusion from the study.