Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04444440
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2020-06-19
Brief Title:
Antibiotic Prophylaxis for Bladder Botox
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed Description:
This study will be a single-centred double-blinded randomized placebo-controlled trial Recruitment will be undertaken at two UrogynecologyUrology sites associated with the University of Alberta in Edmonton Alberta Participants will be randomized to treatment or placebo arm with a 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None