Antibiotic Prophylaxis for Neurogenic Bladder Botox

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ciprofloxacin

    Drug

    Fluoroquinolone antibiotic

  • Placebo

    Drug

    Placebo pill

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Treatment ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
2 weeks following the procedure

Secondary 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)

Time frame
1 and 6 weeks following the procedure
2

Rate of Other Adverse Events

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

Time frame
1, 2 and 6 weeks following the procedure

Other outcomes

Sponsors and contacts

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