Clinical Trial: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome

This study is currently recruiting patients.
Verified by Advanced Bionics August 2005

Sponsored by: Advanced Bionics
Information provided by: Advanced Bionics
ClinicalTrials.gov Identifier: NCT00131573

Purpose

You may be one of millions in the United States who suffers from embarrassing and frustrating bladder control problems. You may have strong and sudden urges to urinate that may be followed by sudden leaks of urine. If other therapies, such as Kegel exercises, behavioral therapy, and medications have not provided relief, you may be eligible to participate in a new clinical research study on Urinary Urgency-Frequency Syndrome.

The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome. This device, which weighs less than 0.03 ounces and measures 1" x 0.1", is implanted into the pelvis to stimulate the pudendal nerve. Stimulation of this nerve is intended to reduce urinary urge and unwanted urination. Participation in this study will be approximately one year of clinic follow-up visits and an annual telephone follow-up consultation for an additional 4 years.

Condition Intervention Phase
Urinary Urgency-Frequency Syndrome
 Device: battery powered bion microstimulator
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title: Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome

Further Study Details: 

Expected Total Enrollment:  110

Study start: June 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria
Participation in this study will be approximately one year of clinic follow-up visits and annual telephone follow-ups for 4 years.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131573


Arizona
      Arizona Health Sciences Center, Tucson,  Arizona,  85724-5077,  United States; Recruiting
Robin Walker  520-626-0033 
Craig Comiter, MD,  Principal Investigator

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Kathleen Noel, RN, MS  202-782-8456    kathleen.noel@na.amedd.army.mil 
Jerome Buller, MD,  Principal Investigator

Minnesota
      Metro Urology, Saint Paul,  Minnesota,  55102,  United States; Recruiting
Cindy Holtz  651-999-7033    research@metro-urology.com 
Steven Siegel, MD,  Principal Investigator

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Susan Rydzinski  216-444-1152    rydzins@ccf.org 
Raymond Rackley, MD,  Principal Investigator

Texas
      Dallas Center for Pelvic Medicine, Dallas,  Texas,  75231,  United States; Recruiting
Lisa Zambrano  214-360-1535    lzambrano@pelvicmed.net 
Brian Feagins, MD,  Principal Investigator

More Information

Study ID Numbers:  CR-B-002
Last Updated:  August 18, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131573
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23



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