Clinical trial NCT01850706: UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation
Official title: Evaluation of Urinary Nerve Growth Factor as an Objective Tool to Assess Therapeutic Outcome in Patients With Detrusor Overactivity Undergoing Treatment With Sacral Neuromodulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detrusor Overactivity
Keywords: uNGF
urinary nerve growth factor
detrusor overactivity
InterStim
sacral neuromodulation
sacral nerve stimulation
quality of life
questionnaire
urodynamic detrusor overactivity
overactive bladder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Medtronics, Inc.
First posted: 2013-05-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over 18 years of age will be screened for eligibility relative to patient inclusion and exclusion criteria. If eligible to enroll, the nature and purpose of this study will be explained to the subject with a witness present. The subject will review and sign the written Informed Consent Form indicating informed consent and voluntary participation in the study. A copy of the consent form including all risks and benefits to research subjects is attached as a separate document.

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.


Eligibility criteria: 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

Primary outcomes:
measure: uNGF level in patients with urodynamically proven DO at baseline versus normal controls
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Correlation between uNGF levels and scores on validated quality of life questionnaires for urinary incontinence
timeFrame: 1 year
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References: