Bacterial Genomic Sequencing in Overactive Bladder
This trial is active, not recruiting.
|Collaborator||Astellas Pharma US, Inc.|
|Start date||July 2012|
|End date||December 2014|
|Trial size||120 participants|
|Trial identifier||NCT01642277, 204195|
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.
Bacterial Genomic Sequencing
time frame: 12 weeks
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.
|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.|
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