Antibiotic Prophylaxis for Neurogenic Bladder Botox

NCT04791579 | Recruiting Phase 2

• 1 other identifier: Pro00108452
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

prophylaxis; post-operative infection; Botox

Outcome Measures

Primary Outcomes (1)

• Rate of Postoperative Urinary Tract Infection

  new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (\>10\^5 CFU/mL)

  2 weeks following the procedure

Secondary Outcomes (2)

• Rate of Postoperative Urinary Tract Infection

  1 and 6 weeks following the procedure

• Rate of Other Adverse Events

  1, 2 and 6 weeks following the procedure

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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

Drug: Ciprofloxacin

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ciprofloxacin DRUG

Fluoroquinolone antibiotic

Treatment Arm

Placebo DRUG

Placebo pill

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18
• Participants must be able to read, speak, and write in English
• 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.
• No contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
• No active antibiotic therapy for any indication at the time of Botox injection
• Not pregnant and/or breastfeeding - Botox is contraindicated in pregnancy (screen serum pregnancy test 72 hrs prior to the procedure is standard of care).

You may not qualify if:

• Participants with idiopathic OAB
• Age \< 18
• Patients who cannot read, speak, and write in English
• 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.
• Any contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
• Active antibiotic therapy for any indication at the time of Botox injection
• Pregnant (as indicated by pre-operative serum quantitative B-hCG for patients aged 18 to 51 without previous hysterectomy) and/or breastfeeding

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Joseph LaBossiere, MD FRCSC

CONTACT

780-407-5958; josephlpmd@gmail.com

Paul Groves, MR FRCSC

CONTACT

709-763-0456; pgroves@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: February 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)