Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05519072
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2022-08-25
Brief Title:
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis By proving this the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance
Participants will be randomized to antibiotic or no treatment arm Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment on the treatment day and 2 days post-treatment Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection UTI symptoms They will be called again at 6 weeks for follow up
Participants will be randomized to antibiotic or no treatment arm Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment on the treatment day and 2 days post-treatment Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection UTI symptoms They will be called again at 6 weeks for follow up
Detailed Description:
Single-centered randomized-controlled trial Participants will be randomized to antibiotic or no treatment arm All subjects will obtain a urine culture approximately 14 days before the procedure Those randomized to the treatment arm will receive oral antibiotics at the discretion of physician in accordance to patients allergies Antibiotics will be administered for 2 days pre-treatment on the treatment day and 2 days post-treatment
Technique and dose of Botox injection will be at the discretion of the operating physician Participants will return for a follow up appointment approximately 2 weeks after treatment as is standard to check a post void residual They will be called again at 6 weeks for follow up The investigators will assess for urinary tract infection symptoms voiding dysfunction and other adverse events potentially related to the prophylactic antibiotics Urine cultures will be collected when possible to confirm infection for patients developing symptoms
For the sample size calculation the investigators assume an alpha α value of 005 and a power of 80 The UTI rate after the bladder Botox procedure is 20 Chapple et al and the investigators have chosen a δ of 20 This was chosen because it was the largest amount the investigators found acceptable to presume the no antibiotic group non-inferior Using these calculations 64 persons are needed per study arm With a 10 drop out rate a total sample size would equal 140 patients total with 70 per arm
If participants are found to meet inclusion criteria they will be contacted by the study team to assess for desired participation in the study If the patient is agreeable to participate a phone or in person consent will be obtained and the patient will be randomized All participants regardless of study arm will have a urine culture collected preoperatively approximately 14 days before procedure If found to have a UTI the participants will be treated accordingly Those in the no antibiotic treatment arm will not receive any antibiotic prophylaxis and will undergo Botox injection Those in the treatment arm will receive oral antibiotics prescribed at discretion of physician in accordance to participants allergies
The primary concern is the development of adverse side effects to antibiotics Subjects will be monitored throughout the study for these potential adverse events by screening for symptoms If an event occurs the PI will be notified immediately It will also be reported to the Institutional Review Board IRB and to all members of the research team
Technique and dose of Botox injection will be at the discretion of the operating physician Participants will return for a follow up appointment approximately 2 weeks after treatment as is standard to check a post void residual They will be called again at 6 weeks for follow up The investigators will assess for urinary tract infection symptoms voiding dysfunction and other adverse events potentially related to the prophylactic antibiotics Urine cultures will be collected when possible to confirm infection for patients developing symptoms
For the sample size calculation the investigators assume an alpha α value of 005 and a power of 80 The UTI rate after the bladder Botox procedure is 20 Chapple et al and the investigators have chosen a δ of 20 This was chosen because it was the largest amount the investigators found acceptable to presume the no antibiotic group non-inferior Using these calculations 64 persons are needed per study arm With a 10 drop out rate a total sample size would equal 140 patients total with 70 per arm
If participants are found to meet inclusion criteria they will be contacted by the study team to assess for desired participation in the study If the patient is agreeable to participate a phone or in person consent will be obtained and the patient will be randomized All participants regardless of study arm will have a urine culture collected preoperatively approximately 14 days before procedure If found to have a UTI the participants will be treated accordingly Those in the no antibiotic treatment arm will not receive any antibiotic prophylaxis and will undergo Botox injection Those in the treatment arm will receive oral antibiotics prescribed at discretion of physician in accordance to participants allergies
The primary concern is the development of adverse side effects to antibiotics Subjects will be monitored throughout the study for these potential adverse events by screening for symptoms If an event occurs the PI will be notified immediately It will also be reported to the Institutional Review Board IRB and to all members of the research team
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?:
False
Is an FDA AA801 Violation?:
None