Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01642277
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2012-07-03
Brief Title:
Bacterial Genomic Sequencing in Overactive Bladder
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
Status:
COMPLETED
Status Verified Date:
2015-10
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:
No one really knows what causes overactive bladder syndrome OAB Urinary tract infection UTIcauses similar symptoms to OAB with the difference being the presence of bacteria as evidenced by routine microbiology cultures Recent work by the group on the genitourinary microbiome GUM has shown that female urine even in the absence of culture evidence of bacteria does have evidence of bacterial DNA Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin a drug used to treat OAB versus those that do not
Detailed Description:
This is a prospective study with two groups Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator control group of women unaffected by OAB All women will have a baseline urine assessment with bacterial genome sequencing Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None