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Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01367886
First received: May 19, 2011
Last updated: June 12, 2013
Last verified: June 2013
  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 (OAB) 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:


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 June, 2013 ] [ 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 June, 2013 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 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 urinary tract infections (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, 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

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 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.

  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 ClinicalTrials.gov identifier: NCT01367886

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: H. Henry Lai, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: 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 12, 2013
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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Fesoterodine
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014