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Bacterial Genomic Sequencing in Overactive Bladder

This study has been completed.
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alan J. Wolfe, Loyola University Identifier:
First received: July 3, 2012
Last updated: October 30, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Overactive Bladder
Drug: Solifenacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome

Resource links provided by NLM:

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Bacterial Genomic Sequencing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.

Secondary Outcome Measures:
  • Assessment of Overactive Bladder Questionnaire (OABQ) [ Time Frame: End of study (Week 12) ] [ Designated as safety issue: No ]
    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).

  • Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).

Enrollment: 134
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women using Solifenacin for OAB treatment
Solifenacin treated women: Women with OAB who are prescribed solifenacin
Drug: Solifenacin
5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Other Name: Vesicare
No Intervention: Control: Women without OAB
Women without OAB who are not prescribed solifenacin.

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.

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01642277

United States, Illinois
Loyola University Chicago Health Sciences Division
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Astellas Pharma US, Inc.
Principal Investigator: Alan J Wolffe, PhD Loyola University Chicago
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alan J. Wolfe, Professor, Microbiology Immunology, Loyola University Identifier: NCT01642277     History of Changes
Other Study ID Numbers: 204195 
Study First Received: July 3, 2012
Results First Received: June 10, 2015
Last Updated: October 30, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Loyola University:
Overactive Bladder
Urinary Tract Infection
16S rRNA sequence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on October 28, 2016