Comparative Urine Proteomic Studies of Overactive Bladder in Humans

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Fesoterodine

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.