Preventing bladder infections after Botox for neurogenic bladder
Prophylactic Antibiotics Following Treatment of Neurogenic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial
PHASE2 · University of Alberta · NCT04791579
This study is testing if giving antibiotics after Botox injections for neurogenic bladder can help prevent urinary tract infections.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04791579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with neurogenic overactive bladder due to conditions like multiple sclerosis, Parkinson's disease, or spinal cord injury.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to Botox or Ciprofloxacin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of post-operative bladder infections in patients receiving Botox for neurogenic bladder.
How similar studies have performed: While the use of prophylactic antibiotics in similar procedures has been explored, this specific approach for Botox injections in neurogenic bladder is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Joseph LaBossiere, MD FRCSC
- Email: josephlpmd@gmail.com
- Phone: 780-407-5958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurogenic Bladder, Post-operative Urinary Tract Infections, prophylaxis, post-operative infection, Botox