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

May 19, 2011
June 12, 2013
August 2010
September 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01367886 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Comparative Urine Proteomic Studies of Overactive Bladder in Humans
Comparative Urine Proteomic Studies of Overactive Bladder in Humans

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Overactive Bladder
Drug: fesoterodine
Fesoterodine 4 mg. tablet by mouth daily for six weeks
Other Name: Toviaz
  • fesoterodine
    Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
    Intervention: Drug: fesoterodine
  • No Intervention: Control
    Control group will not get any study intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367886
WS473527
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: H. Henry Lai, M.D. Washington University School of Medicine
Washington University School of Medicine
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP