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| Name | Class |
|---|---|
| Women and Children's Health Research Institute, Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Active Comparator | Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure |
|
| Placebo Arm | Placebo Comparator | Placebo pill PO every 12 hrs for 3 days following the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | Fluoroquinolone antibiotic. |
| |
| Placebo Pill |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 and 6 weeks following the procedure |
| Rate of Other Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Kelly, MD FRCSC | Contact | 780-735-5290 | eckelly@ualberta.ca | |
| Jane Schulz, MR FRCSC | Contact | 780-970-4659 | schulz@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynecology Clinic - Royal Alexandra Hospital | Recruiting | Edmonton | Alberta | T5H3V9 | Canada |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo
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Placebo
| Other |
Placebo Pill |
|
New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other) |
| 1, 2 and 6 weeks following the procedure |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |