Bacterial Genomic Sequencing in Overactive Bladder

Phase 2

Completed

Conditions: Overactive Bladder

Interventions: Drug: Solifenacin

Registration Number: NCT01642277

Lead Sponsor: Loyola University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 134

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women using Solifenacin for OAB treatment	Solifenacin	Solifenacin treated women: Women with OAB who are prescribed solifenacin

Primary Outcome Measures

Name	Time	Method
Bacterial Genomic Sequencing	12 weeks	Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.

Secondary Outcome Measures

Name	Time	Method
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire	12 weeks	The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = "Not at all" to 4 = "Quite a bit". From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity).
Assessment of Overactive Bladder Questionnaire (OABQ)	End of study (Week 12)	The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).