Bacterial Genomic Sequencing in Overactive Bladder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Loyola University.
Recruitment status was  Recruiting
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alan J. Wolfe, Loyola University Identifier:
First received: July 3, 2012
Last updated: July 17, 2012
Last verified: July 2012

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
Overactive Bladder
Drug: Solifenacin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ]
    This is a prospective cohort study with 2 groups. The first is women accepting clinical treatment for OAB. They will have baseline, week 4 and week 12 urines assessed by bacterial genomic sequencing. The second (control) group of women without OAB will be assessed at baseline only.

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women using Solifenacin for OAB treatment Drug: Solifenacin
5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Other Name: Vesicare
Control: Women without OAB

Solifenacin treated women: Women with OAB who have accepted a clinical recommendation for treatment with solifenacin.

Control women: Women without OAB.

Detailed Description:

This is a prospective cohort study with 2 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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult women who are presenting for treatment of overactive bladder will be approached for participation. Control adult women without OAB will be recruited from adult women presenting for health care in urogynecolgy or general gynecology centers.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01642277

Contact: Alan J Wolfe, PhD 708-216-5814

United States, Illinois
Loyola University Chicago Health Sciences Division Recruiting
Maywood, Illinois, United States, 60153
Contact: Alan J Wolfe, PhD    708-216-5814   
Principal Investigator: Alan J Wolfe, PhD         
Sponsors and Collaborators
Loyola University
Astellas Pharma US, Inc.
Principal Investigator: Alan J Wolffe, PhD Loyola University Chicago
  More Information

No publications provided by Loyola University

Additional 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
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses processed this record on August 20, 2014