Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

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

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

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Detailed Description

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This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Implanted subject

Subjects with Interstim implanted

No interventions assigned to this group

Controls

Subjects without Interstim implanted

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 18-75 years
* Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
* At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
* InterStim® treatment naïve or being revised with a new lead

Exclusion Criteria

* Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
* Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
* Revision of only the IPG (without replacement of the tined lead)
* More than one InterStim® device being placed (undergoing bilateral stimulation)

Controls (n=10)

Inclusion:

* Female
* Age 18-75 years
* Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
* American Urological Association (AUA) symptom score of ≤4

Exclusion:

-History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No