Refractory Overactive Bladder: Sacral Neuromodulation v. Botulinum Toxin Assessment
Some women who suffer from urge urinary incontinence (leakage of urine with a sudden strong sense of urgency to urinate) have tried multiple types of treatments without significant improvements. The next step in treatment is often surgery. The InterStim® neuromodulation system is currently FDA approved for the treatment of urge incontinence. Currently, BOTOX is FDA approved only for people with neurogenic bladder, that is, people who are incontinent but also have a neurological condition such as spinal cord injury or multiple sclerosis.
Researchers are comparing BOTOX injections to InterStim therapy to see which of these treatments improve urge urinary incontinence (for those people without neurogenic bladder) better.
Urge Urinary Incontinence
Women over the age of 21 with urge urinary incontinence that are not currently pregnant and are not planning to become pregnant within 2 years
Have tried at least 2 medications which either did not work or whose side effects prevented continued use
21 - 99
Healthy Volunteers Needed
Duration of Participation
Women's Health Research Unit's confidential recruitment line:
Pelvic Floor Disorders Network
Subjects will receive up to $500 for time and travel related to the completion of each study visit/call. There are a total of six visits and five phone calls.
•$50 following completion of baseline visit
•$30 following completion of month 1 post procedure visit
•$30 following completion of month 2 post procedure call
•$30 following completion of month 3 post procedure visit
•$30 following completion of month 4 post procedure call
•$30 following completion of month 5 post procedure call
•$100 following completion of month 6 post procedure visit
•$25 following completion of month 9 post procedure call
•$50 following completion of 1 year post procedure visit
•$25 following completion of month 18 post procedure call
•$100 after completion of 2 year post procedure visit
Compensation will be mailed to you at the end of each visit/call