Antibiotic Prophylaxis for Neurogenic Bladder Botox

Last updated: February 13, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Urinary Incontinence

Bladder Disorders

Treatment

Placebo

Ciprofloxacin

Clinical Study ID

NCT04791579
Pro00108452
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with neurogenic OAB, defined as OAB associated with a neurologiccondition such as multiple sclerosis, Parkinson's disease, spinal cord injury,previous stroke, or any other neurologic condition the participant may have beentold 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 toxinpreparation or to any of the components in the formulation, symptomatic urinaryretention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatmentif required.

  5. No contraindication to oral Ciprofloxacin - hypersensitivity or allergy toCiprofloxacin or other fluoroquinolone, concurrently taking Tizanidine orAgomelatine.

  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 (screenserum pregnancy test 72 hrs prior to the procedure is standard of care).

  8. No active symptomatic UTI the day of the procedure - wherein the participantpresents the day of their Botox procedure with new or worsening urinary frequency,urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be groundfor exclusion from the study - bladder Botox is contraindicated in patients withactive symptomatic UTI

Exclusion

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 toxinpreparation or to any of the components in the formulation, symptomatic urinaryretention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatmentif required.

  5. Any contraindication to oral Ciprofloxacin - hypersensitivity or allergy toCiprofloxacin or other fluoroquinolone, concurrently taking Tizanidine orAgomelatine.

  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 presentswith new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain,fevers or chills, will be ground for exclusion from the study.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 01, 2025
Estimated Completion Date:
August 31, 2026

Study Description

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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G2R3
    Canada

    Active - Recruiting

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