Bacterial Genomic Sequencing in Overactive Bladder

Completed · Phase 2

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01642277

Run by

Loyola University

People needed

134

Starts

2012-07-01

Expected to finish

2014-08-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: accepted.

You may qualify 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 qualify 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.

Where it is running

• Loyola University Chicago Health Sciences Division — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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