UNGF Assessment in Patients With Detrusor Overactivity Undergoing Sacral Neuromodulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Detrusor Overactivity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

uNGF urinary nerve growth factor detrusor overactivity InterStim sacral neuromodulation sacral nerve stimulation quality of life questionnaire urodynamic detrusor overactivity overactive bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dara Shalom

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-060A

Identifier Type: -

Identifier Source: org_study_id