CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
Solifenacindrug
Likely dose
Solifenacin 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01642277
NCT01642277Phase 2Completed

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

Loyola University·interventional·Posted Jul 17, 2012·Updated Dec 7, 2015

In Brief

A Phase 2 clinical trial evaluating Solifenacin for Overactive Bladder. Completed, enrolled 134 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.0 years ago

Interventions

Solifenacindrug

5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks