Phase 2 N=134 Diagnostic

Bacterial Genomic Sequencing in Overactive Bladder

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT01642277 ↗

Enrolled (actual)

134

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: Bacterial Genomic Sequencing — 25; 11; 3; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Solifenacin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Loyola University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Bacterial Genomic Sequencing	25; 11; 3; 6; 3	—
SECONDARY Assessment of Overactive Bladder Questionnaire (OABQ)	17.50; 37.50; 92.50; 80.00; 97.14; 82.86	.052
SECONDARY Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire	5.77; 7.69; 12.50; 32.50; 8.33; 16.67	.46

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01642277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.