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Search / Trial NCT04444440

Antibiotic Prophylaxis for Bladder Botox

Launched by UNIVERSITY OF ALBERTA · Jun 19, 2020

Trial Information

Current as of August 27, 2025

Recruiting

Keywords

Prophylaxis

ClinConnect Summary

This clinical trial is investigating whether taking antibiotics before and after receiving Botox injections in the bladder can help prevent urinary infections that sometimes occur after the procedure. Botox is used to treat a condition called overactive bladder, which can cause frequent and urgent need to urinate. Researchers will divide participants into two groups: one group will receive the antibiotic Ciprofloxacin, while the other group will receive a placebo (a pill that looks the same but has no active medication). The main goal is to see if the antibiotic reduces the number of urinary infections after the Botox treatment.

To be eligible for the trial, participants must be women aged 18 or older who have been diagnosed with overactive bladder and have not found relief with other treatments. The trial is currently looking for volunteers, and those who join can expect to follow up for six weeks after their Botox procedure. It's important to note that certain conditions, such as having a current urinary infection or being pregnant, will exclude someone from participating. This study aims to improve care for women with overactive bladder by potentially reducing complications from Botox injections.

Gender

FEMALE

Eligibility criteria

  • 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

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Edmonton, Alberta, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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