Bacterial Genomic Sequencing in Overactive Bladder
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | August 2014 |
The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
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.
(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.
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.
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.
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.
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