Clinical trial NCT01367886: Comparative Urine Proteomic Studies of Overactive Bladder in Humans
Official title: Comparative Urine Proteomic Studies of Overactive Bladder in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Urine proteomics
overactive bladder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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: 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 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.

Primary outcomes:
measure: Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
timeFrame: Outcome measure was assessed at baseline and at the end of the 6-week treatment
measure: Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment
timeFrame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.
Secondary outcomes:
measure: Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.
timeFrame: Outcome measure was assessed at baseline and after the 6 week visit.
measure: Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..
timeFrame: Outcome measures were assessed at baseline and after the 6 week visit.
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: H. Henry Lai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: