Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04817865
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2021-03-23
Brief Title:
Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection
Sponsor:
Pathnostics
Organization:
Pathnostics
Study Overview
Official Title:
A Retrospective Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox for the Treatment of Neurogenic or Non-neurogenic Overactive Bladder
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder OAB
Detailed Description:
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by a previous prospective comparison study This is a retrospective record review comparing PCR and culture-based assessments for UTI in patients receiving Botox injection to treat overactive bladder OAB Investigators aim to determine whether M-PCRP-AST can be utilized as a screening method for UTI in these patients and whether whether antibiotic prophylaxis peri-procedural antibiotics and post-injection antibiotic therapy based on patients pre-procedural M-PCRP-AST results in improved response to Botox injection compared to standard of care The attributes and advantages of PCR testing over the use of traditional urine cultures and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms may significantly improve patient care
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?:
None
Is an FDA AA801 Violation?:
None