UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation

Detrusor Overactivity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850706
• Other study ID #: 11-060A
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: October 24, 2016
• Start date: August 2011
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Detrusor Overactivity

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Medtronics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uNGF level in patients with urodynamically proven DO at baseline versus normal controls		1 year	No
Primary	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	No
Secondary	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	No
Secondary	Correlation between uNGF levels and scores on validated quality of life questionnaires for urinary incontinence		1 year	No