UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation

Completed

• Conditions: Detrusor Overactivity

• Registration Number: NCT01850706
• Lead Sponsor: Northwell Health

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 working, and determine if patients are good candidates for interventions like sacral neuromodulation/Interstim Therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Status Verified: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
uNGF level in patients with urodynamically proven DO at baseline versus normal controls	1 year
Change in uNGF levels in patients with urodynamic DO at baseline and 5 days, 1 month, 3 months, and 12 months after treatment with Interstim	1 year

Secondary Outcome Measures

Name	Time	Method
Change in quality of life questionnaire scores in patients with urodynamic DO at baseline and at 5 days, 1 month, 3 months, and 12 months after treatment with Interstim	1 year
Correlation between uNGF levels and scores on validated quality of life questionnaires for urinary incontinence	1 year

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States