Overactive Bladder
Conditions
Brief summary
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.
Detailed description
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.
Interventions
None listed
Sponsors
Corewell Health East
Michael Chancellor, MD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
OAB subjects (n=10 Phase I and n=10 Phase II) Inclusion Criteria: * Female * Age 18-75 years * Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit. * At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary. * InterStim® treatment naïve or being revised with a new lead
Exclusion criteria
* Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review * Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I) * Revision of only the IPG (without replacement of the tined lead) * More than one InterStim® device being placed (undergoing bilateral stimulation) Controls (n=10) Inclusion: * Female * Age 18-75 years * Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence) * American Urological Association (AUA) symptom score of ≤4 Exclusion: -History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve Growth Factor (NGF) levels | 4 weeks | pg/ml |
Countries
United States
Outcome results
None listed