Status:
COMPLETED
UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Medtronics, Inc.
Conditions:
Detrusor Overactivity
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to find a noninvasive test to help physicians diagnose detrusor overactivity (DO), to use this urine test to help diagnose bladder problems, determine if treatments are wo...
Eligibility Criteria
Inclusion
- for controls: age greater than or equal to 18; female gender, ability to provide informed consent and complete study requirements; subject has to be without urinary symptoms
- for cases: age greater than or equal to 18; female gender; ability to provide informed consent and complete study requirements; the subject should have symptoms of detrusor overactivity, including urinary frequency, urgency, or urge incontinence, for greater than or equal to 3 months; urodynamic diagnosis of detrusor overactivity; failed treatment with behavioral modification and anticholinergic medication
Exclusion
- active urinary tract infection; currently undergoing hemodialysis or has severe renal impairment; bladder tumors; uncontrolled diabetes mellitus; post void residual greater than 100ml; history of use of anticholinergic treatment within past 21 days; history of urinary tract operation within 6 months prior to screening; heart failure; uncontrolled hypertension; severe neurological disease; history of botox usage within 1 year
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01850706
Start Date
August 1 2011
End Date
March 1 2016
Last Update
October 26 2016
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030