UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation

NCT01850706 | Completed

• 1 other identifier: 11-060A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Medtronics, Inc.: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: August 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2015-10

Locations

US (1)