Bacterial Genomic Sequencing in Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin
Intervention description: 5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Overactive Bladder; OAB; Urinary Tract Infection; UTI; Microbiome; Bacteria; Solifenacin; 16S rRNA sequence

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.
    

Eligibility criteria:

        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.