Millions in the United States suffer from embarrassing and frustrating bladder control problems such as urinary urge incontinence. Urinary urge incontinence is typically defined as strong and sudden urges to urinate followed by sudden losses (leaks) of urine. Conservative therapies such as Kegel exercises, behavioral therapy and medications work well for many patients, but some remain refractory (or have not received benefit from these conservative therapies).

This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies. The device, weighing less than 0.03 ounces and measuring 1.0” x 0.1”, stimulates a nerve located in the pelvic region, called the pudendal nerve. It is hoped that stimulation of this nerve can reduce urge and unwanted urination.

Condition	Treatment or Intervention	Phase
Urinary Incontinence	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.

California
      The Department of Urology, Stanford University Medical Center, Stanford,  California,  94305-5118,  United States; Recruiting
Colorado
      Urogynecology Associates of Colorado, Denver,  Colorado,  80220,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Kansas
      The Urogynecology Center, Overland Park Regional Medical Center, Overland Park,  Kansas,  66215,  United States; No longer recruiting

Study ID Numbers:  CR-B-001, Rev. G
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  April 1, 2004
ClinicalTrials.gov Identifier:  NCT00080470
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08