NCT01642277

Bacterial Genomic Sequencing in Overactive Bladder

The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Solifenacin	5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-07-17
• Last updated: 2015-12-07
• Results posted: 2015-12-07

Locations

1 site across 1 country: United States