Comparative Urine Proteomic Studies of Overactive Bladder in Humans

The Washington University

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: fesoterodine

Study type: Interventional

Funder types: Other

Identifiers

NCT01367886

WS473527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

Fesoterodine

Other group

Description:

Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Treatment:

Drug: fesoterodine