Preventing bladder infections after Botox for neurogenic bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of prophylactic antibiotics in preventing post-operative urinary tract infections following Botox injections for neurogenic overactive bladder. Participants will be randomly assigned to receive either antibiotics or a placebo after the procedure, with both patients and surgeons blinded to the treatment allocation. The study will collect urine cultures and symptom questionnaires over a six-week follow-up period to assess infection rates and other related outcomes. The goal is to determine if antibiotics can improve safety and outcomes for this common urologic procedure.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Joseph LaBossiere, MD FRCSC
• Email: josephlpmd@gmail.com
• Phone: 780-407-5958

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.