Bacterial Genomic Sequencing in Overactive Bladder
Information source: Loyola University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Solifenacin (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Loyola University Official(s) and/or principal investigator(s): Alan J Wolffe, PhD, Principal Investigator, Affiliation: Loyola University Chicago
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.
Clinical Details
Official title: The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Bacterial Genomic Sequencing
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 89 Years.
Gender(s): Female.
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.
Locations and Contacts
Loyola University Chicago Health Sciences Division, Maywood, Illinois 60153, United States
Additional Information
Starting date: July 2012
Last updated: September 8, 2014
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