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: February 10, 2015
Last verified: February 2015
  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: 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:
  • Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment [ Time Frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment ] [ Designated as safety issue: No ]
    Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.

  • Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment [ Time Frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period. ] [ Designated as safety issue: No ]
    The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.


Secondary Outcome Measures:
  • Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks. [ Time Frame: Outcome measure was assessed at baseline and after the 6 week visit. ] [ Designated as safety issue: No ]
    Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.

  • Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks.. [ Time Frame: Outcome measures were assessed at baseline and after the 6 week visit. ] [ Designated as safety issue: No ]
    Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.


Enrollment: 21
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

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
Results First Received: July 9, 2013
Last Updated: February 10, 2015
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 July 29, 2015