Bacterial Genomic Sequencing in Overactive Bladder
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Purpose
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 |
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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| Contact: Alan J Wolfe, PhD | 708-216-5814 | awolfe@lumc.edu |
| United States, Illinois | |
| Loyola University Chicago Health Sciences Division | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Alan J Wolfe, PhD 708-216-5814 awolfe@lumc.edu | |
| Principal Investigator: Alan J Wolfe, PhD | |
| Principal Investigator: | Alan J Wolffe, PhD | Loyola University Chicago |
More Information
No publications provided
| Responsible Party: | Alan J. Wolfe, Professor, Microbiology Immunology, Loyola University |
| ClinicalTrials.gov 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 OAB Urinary Tract Infection UTI |
Microbiome Bacteria Solifenacin 16S rRNA sequence |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013