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Completed

NCT Number: NCT01850706

UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. uNGF level in patients with urodynamically proven DO at baseline versus normal controls

    Time frame: 1 year

  2. 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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. Correlation between uNGF levels and scores on validated quality of life questionnaires for urinary incontinence

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Medtronics, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 9, 2013
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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