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Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study is currently recruiting participants.
Verified June 2011 by Washington University School of Medicine
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01367886
First received: May 19, 2011
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  Purpose

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 from a simple voided urine specimen.


Condition Intervention
Overactive Bladder
 Drug: fesoterodine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comparative Urine Proteomic Studies of Overactive Bladder in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Decrease in frequency and urgency of urination will be measured based on the three-day bladder diary submitted before start of medication and the three-day bladder diary submitted at the end of 6 weeks. [ Time Frame: Outcome measure will be assessed after the 6 week visit and data will be presented in 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in frequency and urgency of urination will be measured based on the answers to the Overactive Bladder Questionnaire at the baseline visit and at the 6 week visit (Overactive Bladder Treatment Satisfaction Questionnaire at 6 week visit). [ Time Frame: Outcome measure will be assessed after the 6 week visit and data will be presented in 1 year. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
fesoterodine
Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
 Drug: fesoterodine
Fesoterodine 4 mg. tablet by mouth daily for six weeks
Other Name: Toviaz
No Intervention: Control
Control group will not get any study intervention

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For healthy volunteers the inclusion criteria are:

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

For overactive bladder patients the inclusion criteria are

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

Exclusion Criteria:

For healthy volunteers the exclusion criteria are:

  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, 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

For overactive bladder patients the exclusion criteria are:

  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 IC or pain associated with OAB
  8. Urinary retention requiring catheterization, indwelling catheter of Self-cath
  9. Recurrent 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367886

Contacts
Contact: Henry Lai, M.D. 314-454-8149 laih@wudosis.wustl.edu
Contact: Vivien C. Gardner, BSN 314-996-8285 gardnerv@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Henry Lai, M.D.     314-454-8149        
Principal Investigator: Henry Lai, M.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Henry Lai, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: H. Henry Lai, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01367886     History of Changes
Other Study ID Numbers: WS473527
Study First Received: May 19, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Urine proteomics
overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013