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

Completed

Conditions studied: Overactive Bladder

In brief

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

Key facts

Study ID

NCT01739946

Run by

Michael Chancellor, MD

People needed

30

Starts

2012-10-01

Expected to finish

2016-12-01

Last updated by the study team

2017-08-01

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.