Expired Study
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Clinical Trial 9852

Sarasota, FL 34237

Study Summary:

We are conducting a 5 year study for patients who have been diagnosed with Overactive Bladder (OAB). This may include loss of urine with a strong need to use the bathroom, called urge incontinence (UI). If you do not have loss of urine, you may also have an overactive bladder if you make many trips to the bathroom, called urgency-frequency (UF).

The purpose of this study is:
To help find out which symptoms might be helped the most by using the InterStim® Therapy
To learn more about how the InterStim® Therapy may affect bowel function(stool), sexual function, mental depression, and pain in the pelvic area
To measure how your symptoms of overactive bladder affect your daily
To learn more about how safe the tined lead is over a long period of time

Qualified Participants Must:

• Be 18 years of age or older
• Have Overactive bladder (OAB) symptoms
• Have failed or not a candidate for more conservative treatment (pelvic floor training, biofeedback, behavioral modification)
• Have failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least 1 or more OAB medication
• Be willing to discontinue all OAB medications prior to participation

Qualified Participants May Receive:

Qualified participants will receive study InterStim® device, study related physical exams, (at no cost), and compensations for time and travel.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.