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Bacterial Genomic Sequencing in Overactive Bladder

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Solifenacin

About this trial

This is an interventional diagnostic trial for Overactive Bladder focused on measuring Overactive Bladder, OAB, Urinary Tract Infection, UTI, Microbiome, Bacteria, Solifenacin, 16S rRNA sequence

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Loyola University Chicago Health Sciences Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Women using Solifenacin for OAB treatment

Control: Women without OAB

Arm Description

Solifenacin treated women: Women with OAB who are prescribed solifenacin

Women without OAB who are not prescribed solifenacin.

Outcomes

Primary Outcome Measures

Bacterial Genomic Sequencing

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)

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

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).

Full Information

NCT ID

NCT01642277

First Posted

July 3, 2012

Last Updated

October 30, 2015

Sponsor

Loyola University

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01642277

Brief Title

Bacterial Genomic Sequencing in Overactive Bladder

Official Title

The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loyola University

Collaborators

Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Overactive Bladder, OAB, Urinary Tract Infection, UTI, Microbiome, Bacteria, Solifenacin, 16S rRNA sequence

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Women using Solifenacin for OAB treatment

Arm Type

Experimental

Arm Description

Solifenacin treated women: Women with OAB who are prescribed solifenacin

Arm Title

Control: Women without OAB

Arm Type

No Intervention

Arm Description

Women without OAB who are not prescribed solifenacin.

Intervention Type

Drug

Intervention Name(s)

Solifenacin

Other Intervention Name(s)

Vesicare

Intervention Description

5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Primary Outcome Measure Information:

Title

Bacterial Genomic Sequencing

Description

Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Assessment of Overactive Bladder Questionnaire (OABQ)

Description

Time Frame

End of study (Week 12)

Title

Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan J Wolffe, PhD

Organizational Affiliation

Loyola University Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University Chicago Health Sciences Division

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

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Citation

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Bacterial Genomic Sequencing in Overactive Bladder

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