Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05719285
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2023-01-23
Brief Title:
Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder
The main question it aims to answer are
Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics
Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection
Researchers will compare incidence of UTI in each group to see if there is a significant difference
The main question it aims to answer are
Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics
Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection
Researchers will compare incidence of UTI in each group to see if there is a significant difference
Detailed Description:
After informed consent is obtained urinalysis will be collected Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months
Patients with positive urinalysis and symptomatic for UTI will be excluded from the study
Patients will be randomized in a 11 ratio to one of two groups
Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection
Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection
The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patients pharmacy
Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeons standard technique and template
Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute
Patients will be followed for 4 weeks after the procedure
At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period
Chart review will occur at 4 weeks to assess for any unreported events
Other than this additional phone call post-operative patient management will not deviate from the standard of care
Patients will be instructed to report symptomatic UTIs urinary retention or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators
Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture
Symptomatic culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines
Symptoms suggestive of urinary retention such as increased urinary frequency voiding small amounts of urine or feelings of incomplete bladder emptying will result in obtaining a post void residual PVR and urinalysis
Patients will undergo teaching to perform self clean intermittent catheterization of the bladder per the discretion of the operating surgeon
Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction
Antibiotic regimens
Allergy prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth
First line
Group 1 trimethoprim sulfamethoxazole 800160 mg once pre-procedure Group 2 trimethoprim sulfamethoxazole 800160 mg once pre-procedure plus 800160 mg every twelve hours for 6 total doses
Second line
Group 1 cefalexin 500 mg once pre-procedure Group 2 cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line
Group 1 nitrofurantoin 100 mg once pre-procedure Group 2 nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line
Group 1 ciprofloxacin 500 mg once pre-procedure Group 2 ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Patients with positive urinalysis and symptomatic for UTI will be excluded from the study
Patients will be randomized in a 11 ratio to one of two groups
Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection
Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection
The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patients pharmacy
Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeons standard technique and template
Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute
Patients will be followed for 4 weeks after the procedure
At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period
Chart review will occur at 4 weeks to assess for any unreported events
Other than this additional phone call post-operative patient management will not deviate from the standard of care
Patients will be instructed to report symptomatic UTIs urinary retention or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators
Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture
Symptomatic culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines
Symptoms suggestive of urinary retention such as increased urinary frequency voiding small amounts of urine or feelings of incomplete bladder emptying will result in obtaining a post void residual PVR and urinalysis
Patients will undergo teaching to perform self clean intermittent catheterization of the bladder per the discretion of the operating surgeon
Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction
Antibiotic regimens
Allergy prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth
First line
Group 1 trimethoprim sulfamethoxazole 800160 mg once pre-procedure Group 2 trimethoprim sulfamethoxazole 800160 mg once pre-procedure plus 800160 mg every twelve hours for 6 total doses
Second line
Group 1 cefalexin 500 mg once pre-procedure Group 2 cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line
Group 1 nitrofurantoin 100 mg once pre-procedure Group 2 nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line
Group 1 ciprofloxacin 500 mg once pre-procedure Group 2 ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None