Antibiotic Prophylaxis for Neurogenic Bladder Botox
Antibiotic Prophylaxis for Neurogenic Bladder Botox
Injection of Botox into the bladder is a procedure used to treat neurogenic overactive
 bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common
 complication following bladder Botox is bladder infection. There are no well-studied
 preventative antibiotics given at the time of bladder Botox for the reduction of
 post-operative bladder infection. We are proposing a research study that will randomize
 participants into two groups - one receiving antibiotics and the other receiving placebo
 pills following bladder Botox. The main goal of our study is to determine if preventative
 antibiotics at the time of bladder Botox injection reduces post-operative bladder infection.
 It will provide a valuable learning opportunity for a trainee starting their academic career
 through working closely with established researchers across two disciplines. We hope the
 results of our study can ultimately be used to improve outcomes and safety for a common
 Urologic procedure. In addition, findings from our study could help reduce unnecessary use of
 antibiotics resulting in cost savings in the health care system and reduction in the risk of
 antibiotic resistance.
This study will be a single-centred, double-blinded, randomized, placebo- controlled trial.
 Recruitment will be undertaken in the Urology clinic in the Urology Centre at the Kaye
 Edmonton Clinic in Edmonton, AB. Participants will be randomized to treatment or placebo arm
 with a 1:1 allocation ratio. Patients and surgeons will be blinded.

 On the day of the procedure, a urine culture will be collected preoperatively to identify
 pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of
 the operating physician. Trigone-sparing technique with injection of 200 units of Botox
 distributed across 10 to 20 sites is generally used at our centre.

 Follow-up will occur over a six-week postoperative period. A questionnaire will be used at
 each follow-up encounter to screen patients for urinary tract infection symptoms, voiding
 dysfunction, and other adverse events potentially related to the prophylactic antibiotics.
 Urine cultures will be collected to confirm infection for patients developing postoperative
 symptoms.
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.