Overview

This trial is active, not recruiting.

Condition overactive bladder
Treatment solifenacin
Sponsor Loyola University
Collaborator Astellas Pharma US, Inc.
Start date July 2012
End date December 2014
Trial size 120 participants
Trial identifier NCT01642277, 204195

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
solifenacin Vesicare
5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Solifenacin treated women: Women with OAB who have accepted a clinical recommendation for treatment with solifenacin. Control women: Women without OAB.

Primary Outcomes

Measure
Bacterial Genomic Sequencing
time frame: 12 weeks

Eligibility Criteria

Female participants from 18 years up to 89 years old.

Inclusion Criteria: - Controls: Women without bother from urinary symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with negative urinary responses will be further screened for participation using the following eligibility criteria: - no anticholinergic medications for bladder conditions, - no antibiotic exposure in the past 4 weeks for any reason, - no immunologic deficiency, - no pelvic malignancy or pelvic radiation, and - Untreated symptomatic POP > POP-Q Stage II. OAB cohort: Women with bother from overactive bladder symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with positive urinary responses for urge predominant symptoms will be further screened for participation using the following eligibility criteria: - willing to take Solifenacin as treatment for OAB, - no neurological disease known to affect the lower urinary tract, - no current UTI (based on urine dipstick) or recurrent UTI, - no antibiotic exposure in the past 4 weeks for any reason, - no immunologic deficiency, - no pelvic malignancy or pelvic radiation, - untreated symptomatic POP > POP-Q Stage II, - no contraindications to receiving Solifenacin. Exclusion Criteria: - Women who are of child-bearing potential who are pregnant, nursing, intending to become pregnant during the study or not practicing a reliable form of contraception are also excluded.

Additional Information

Official title The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
Principal investigator Alan J Wolffe, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Loyola University.