Clinical trial NCT01642277: Bacterial Genomic Sequencing in Overactive Bladder
Official title: The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Overactive Bladder
OAB
Urinary Tract Infection
UTI
Microbiome
Bacteria
Solifenacin
16S rRNA sequence
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2012-07-17
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Bacterial Genomic Sequencing
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of Overactive Bladder Questionnaire (OABQ)
timeFrame: End of study (Week 12)
measure: Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago Health Sciences Division
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Alan J Wolffe, PhD
role: PRINCIPAL_INVESTIGATOR
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