Comparative Urine Proteomic Studies of Overactive Bladder in Humans
Completed · Not applicable
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT01367886
- Run by
- Washington University School of Medicine
- People needed
- 21
- Starts
- 2010-08-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2015-02-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- For healthy volunteers the inclusion criteria are:
- Females ≥ 18 years old
- Not experiencing overactive bladder symptoms
- Not experiencing frequency or urgency
- For overactive bladder patients the inclusion criteria are
- Females ≥ 18 years old
- Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year
You may not qualify if…
- For healthy volunteers the exclusion criteria are:
- Overactive bladder symptoms, such as frequency and urgency
- Intermittent/unstable use of bladder medications
- Pregnant women or women unwilling to use contraceptives
- Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
- Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
- Lower urinary tract surgery within past 6 months
- Known history of IC or pain associated with OAB
- Urinary retention requiring catheterization, indwelling catheter of Self-cath
- Recurrent UTIS > 3/year
- For overactive bladder patients the exclusion criteria are:
- Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
- Intermittent/unstable use of bladder medications
- Pregnant women or women unwilling to use contraceptives
- Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
- Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
- Lower urinary tract surgery within past 6 months
- Known history of Interstitial Cystitis (IC) or pain associated with OAB
- Urinary retention requiring catheterization, indwelling catheter of Self-cath
- 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.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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