Bacterial Genomic Sequencing in Overactive Bladder
|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:||December 2014|
|Estimated Primary Completion Date:||December 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
|United States, Illinois|
|Loyola University Chicago Health Sciences Division|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Alan J Wolffe, PhD||Loyola University Chicago|