Bacterial Genomic Sequencing in Overactive Bladder

Loyola University

Status and phase

Completed

Phase 2

Conditions

Overactive Bladder

Treatments

Drug: Solifenacin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01642277

204195

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

Female

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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.