ROSETTA Study to compare two therapies in women with overactive bladder

Participating in study as part of national Pelvic Floor Disorders Network

Overactive bladder, or the sudden urge to urinate, affects the quality of life of many women. Studies have shown that not all women respond to or can tolerate oral medications and may benefit from other therapies.

Women & Infants Hospital of Rhode Island is conducting a study to compare the effect of two therapies in women who have bothersome urinary urge incontinence after trying other treatments. Patients are currently being enrolled in the ROSETTA Study - Reftractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment. The ROSETTA Study is part of the national Pelvic Floor Disorders Network which is funded by the National Institute of Child Health and Development and the Office of Research on Women's Health.

Principal investigator at Women & Infants is Deborah Myers, MD, director of the Division of Urogynecology and Reconstructive Pelvic Surgery at Women & Infants and at The Warren Alpert Medical School of Brown University.

"There are more than 10 million women who suffer from incontinence in America today and more than 50,000 women in Rhode Island alone. That's about one in four between the ages of 30 and 59," said Dr. Myers. "For some women, medications and physical therapy may not help. If we can find another therapy option for these women, we can dramatically impact their quality of life. That's what studies like ROSETTA are all about."

The ROSETTA Study will compare the effect of two therapies in women who have bothersome urinary urge incontinence after trying other treatments. The two new treatments are:

• Botox-, a medication injected into the bladder, or
• InterStim- Therapy, a reversible treatment that uses mild electrical pulses to stimulate nerves going to the bladder (neuromodulation) that influence bladder function.

Women who may be eligible to participate are over 21 years of age, report symptoms of urge incontinence or overactive bladder, experience this leakage two or more times a day, and have tried other treatments including oral medication. Participation will include receiving one of the two procedures and monthly office visits or telephone follow-up for six months and follow-up every three to six months for 24 months.