Recruiting
Phase 2

Antibiotic Prophylaxis

Sponsor:

University of Alberta

Code:

NCT04791579

Conditions

Neurogenic Bladder

Post-operative Urinary Tract Infections

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ciprofloxacin

Placebo

Study Details

Brief 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.

Conditions

Neurogenic Bladder

Post-operative Urinary Tract Infections

Study ID

NCT04791579

Start date

Feb 1, 2025

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Treatment Arm

Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure

placebo comparator: Placebo Arm

Placebo pill PO every 12 hrs for 3 days following the procedure

Interventions

Ciprofloxacin

Fluoroquinolone antibiotic

Placebo

Placebo pill

Primary outcome measure

  • Rate of Postoperative Urinary Tract Infection [ Time Frame: 2 weeks following the procedure ]

Central Contacts and Locations

Central contacts

Joseph LaBossiere, MD FRCSC

780-407-5958josephlpmd@gmail.com

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

Joseph LaBossiere, MD FRCSC

780-407-5958josephlpmd@gmail.com

More Information

Sponsor

University of Alberta

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • prophylaxis
  • post-operative infection
  • Botox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-07.