N/A N=21

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT01367886 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment — 12.32; 10.79 urinations/day — p=0.19

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: fesoterodine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Washington University School of Medicine
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment	12.32; 10.79	0.19
PRIMARY Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment	2.84; 2.50	0.18
SECONDARY Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.	4.89; 3.50	0.0021 sig
SECONDARY Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..	4.52; 3.14	0.0025 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01367886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.