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

Further Study Details: 

Expected Total Enrollment:  110

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00131573

Arizona
      Arizona Health Sciences Center, Tucson,  Arizona,  85724-5077,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Minnesota
      Metro Urology, Saint Paul,  Minnesota,  55102,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Texas
      Dallas Center for Pelvic Medicine, Dallas,  Texas,  75231,  United States; Recruiting

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