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NCT Number: NCT04444440

Antibiotic Prophylaxis for Bladder Botox

Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported side effects between the two groups possibly related to antibiotic use. Follow-up will be over six weeks following the procedure.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

Location status: Recruiting

Location contact

Erin Kelly, MD FRCSC

CONTACT

[email protected]

7807355290

Erin Kelly, MD FRCSC

PRINCIPAL_INVESTIGATOR

Jane Schulz, MD FRCSC

SUB_INVESTIGATOR

Paul Groves, MD FRCSC

CONTACT

[email protected]

7809991561

Paul Groves, MD FRCSC

SUB_INVESTIGATOR

About this study

This study will be a single-centred, double-blinded, randomized, placebo-controlled trial. Recruitment will be undertaken at two Urogynecology/Urology sites associated with the University of Alberta in Edmonton, Alberta. 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 100 to 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with idiopathic OAB diagnosed clinically who have failed medical management
  • Female
  • Age ≥ 18

Exclusion criteria

  • Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other)
  • Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
  • Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14
  • Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic.
  • Male
  • Age < 18
  • Pregnant and/or breastfeeding

Treatment and study plan

Ciprofloxacin

Drug

Fluoroquinolone antibiotic.

Placebo pill

Other

Placebo Pill

Primary outcomes

  1. Rate of Postoperative Urinary Tract Infection

    Time frame: 2 weeks following the procedure

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

Secondary outcomes

  1. Rate of Postoperative Urinary Tract Infection Rate

    Time frame: 1 and 6 weeks following the procedure

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

  2. Rate of Other Adverse Events

    Time frame: 1, 2 and 6 weeks following the procedure

    New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Kelly, MD FRCSC

CONTACT

[email protected]

780-735-5290

Jane Schulz, MR FRCSC

CONTACT

[email protected]

780-970-4659

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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