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Keep this study
Lead
Loyola University
With
Astellas Pharma US, Inc.
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.
Age
18–89
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Bacterial Genomic Sequencing in Overactive Bladder
