Idiopathic Overactive BladderPhase 4NCT04444440
Antibiotic Prophylaxis for Bladder Botox
A Phase 4 study testing Ciprofloxacin in people with Idiopathic Overactive Bladder and Postoperative Urinary Tract Infection, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2021to 30 Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic OAB diagnosed clinically who have failed medical management
- Female
- Age ≥ 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Urogynecology Clinic - Royal Alexandra Hospital
Edmonton, Alberta, T5H3V9
Erin Kelly, MD FRCSC, 7807355290, eckelly@ualberta.ca
Paul Groves, MD FRCSC, 7809991561, pgroves@ualberta.ca
About this study
Official title: Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial
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.
Read the detailed description
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.
- Being tested
- Ciprofloxacin, Placebo Pill
- Keywords
- prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Fluoroquinolone antibiotic.
Placebo PillOther
Placebo Pill
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure Receives: Drug: Ciprofloxacin |
| Placebo Arm | Placebo comparator | Placebo pill PO every 12 hrs for 3 days following the procedure Receives: Other: Placebo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks following the procedure
Secondary outcomes (2)
Rate of Postoperative Urinary Tract Infection Rate
new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)
Measured: 1 and 6 weeks following the procedure
Rate of Other Adverse Events
New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)
Measured: 1, 2 and 6 weeks following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start28 Jun 2021
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444440
- Sponsor's protocol ID
- Pro00101838
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2020
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No