Bacterial Genomic Sequencing in Overactive Bladder
Recruitment status was Recruiting
No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome|
- Bacterial Genomic Sequencing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]This is a prospective cohort study with 2 groups. The first is women accepting clinical treatment for OAB. They will have baseline, week 4 and week 12 urines assessed by bacterial genomic sequencing. The second (control) group of women without OAB will be assessed at baseline only.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Women using Solifenacin for OAB treatment||
5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Other Name: Vesicare
Control: Women without OAB
Solifenacin treated women: Women with OAB who have accepted a clinical recommendation for treatment with solifenacin.
Control women: Women without OAB.
This is a prospective cohort study with 2 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642277
|Contact: Alan J Wolfe, PhDfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Chicago Health Sciences Division||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Alan J Wolfe, PhD 708-216-5814 email@example.com|
|Principal Investigator: Alan J Wolfe, PhD|
|Principal Investigator:||Alan J Wolffe, PhD||Loyola University Chicago|