Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

• After informed consent is obtained, urinalysis will be collected. Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months.
• Patients with positive urinalysis and symptomatic for UTI will be excluded from the study.
• Patients will be randomized in a 1:1 ratio to one of two groups.

• Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
• Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.
• The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy.
• Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeon's standard technique and template.
• Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute.
• Patients will be followed for 4 weeks after the procedure.
• At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period.
• Chart review will occur at 4 weeks to assess for any unreported events.
• Other than this additional phone call, post-operative patient management will not deviate from the standard of care.
• Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators.
• Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture.
• Symptomatic, culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines.
• Symptoms suggestive of urinary retention, such as increased urinary frequency, voiding small amounts of urine, or feelings of incomplete bladder emptying, will result in obtaining a post void residual (PVR) and urinalysis.
• Patients will undergo teaching to perform self, clean intermittent catheterization of the bladder per the discretion of the operating surgeon.
• Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction.

Antibiotic regimens:

Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.

First line:

Group 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Group 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses

Second line:

Group 1: cefalexin 500 mg once pre-procedure Group 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses

Third line:

Group 1: nitrofurantoin 100 mg once pre-procedure Group 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses

Fourth line:

Group 1: ciprofloxacin 500 mg once pre-procedure Group 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses

Inclusion criteria

• Participants with planned in-office bladder onabotulinumtoxinA injection
• Men or Women Age ≥ 18
• Able to read, speak, and write in English
• No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
• Willingness and ability to initiate intermittent catheterization post-treatment if required
• No contraindication to oral antibiotics
• No active antibiotic therapy for any indication at the time of onabotulinumtoxinA injection
• Have not participated in this study before

Exclusion criteria

• Any type of catheterization to empty the bladder
• Unwillingness or inability to initiate intermittent catheterization post-treatment if required
• Less than 3 months since last bladder onabotulinumtoxinA injection
• Pregnant and/or breastfeeding
• Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills
• History of recurrent UTI
• Prior development of urinary retention or incomplete bladder emptying after bladder onabotulinumtoxinA injection requiring catheterization of any type