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Comparative Urine Proteomic Studies of Overactive Bladder in Humans

NCT ID: NCT01367886

Last Updated: 2015-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-09-30

Brief Summary

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This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.

Detailed Description

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The objectives of the study are:

1. to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
2. to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Conditions

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Overactive Bladder

Keywords

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Urine proteomics overactive bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Fesoterodine

Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Group Type OTHER

fesoterodine

Intervention Type DRUG

Fesoterodine 4 mg. tablet by mouth daily for six weeks

Interventions

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fesoterodine

Fesoterodine 4 mg. tablet by mouth daily for six weeks

Intervention Type DRUG

Other Intervention Names

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Toviaz

Eligibility Criteria

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Inclusion Criteria

1. Females ≥ 18 years old
2. Not experiencing overactive bladder symptoms
3. Not experiencing frequency or urgency


1. Females ≥ 18 years old
2. Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) \> 3/year

Exclusion Criteria

1. Overactive bladder symptoms, such as frequency and urgency
2. Intermittent/unstable use of bladder medications
3. Pregnant women or women unwilling to use contraceptives
4. Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
6. Lower urinary tract surgery within past 6 months
7. Known history of IC or pain associated with OAB
8. Urinary retention requiring catheterization, indwelling catheter of Self-cath
9. Recurrent UTIS \> 3/year


1. Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
2. Intermittent/unstable use of bladder medications
3. Pregnant women or women unwilling to use contraceptives
4. Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
6. Lower urinary tract surgery within past 6 months
7. Known history of Interstitial Cystitis (IC) or pain associated with OAB
8. Urinary retention requiring catheterization, indwelling catheter of Self-cath
9. Recurrent urinary tract infections (UTIS) \> 3/year

Deferral Criteria:

Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H. Henry Lai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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WS473527

Identifier Type: -

Identifier Source: org_study_id