Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment
Studying therapies to relieve urinary urge incontinence
What is the ROSETTA Study?
The ROSETTA study will compare the effect of two therapies in women who have bothersome urinary urge incontinence after trying other treatments.
The two therapies are:
Botox®, a medication injected into the bladder
InterStim® Therapy, a reversible treatment that uses mild electrical pulses to stimulate nerves going to your bladder (neuromodulation) that influence bladder function
Participation will last up to two years.
Who is eligible to participate in this study?
You may be eligible to participate in this study if you:
- are a woman who reports symptoms of urge incontinence or overactive bladder (OAB)
- are 21 years of age or older
- experience this leakage two or more times per day
- have tried other treatments for OAB including oral medication
Why is this study important?
Many women experience accidental loss of urine called urinary urge incontinence or overactive bladder. Studies have shown that not all women respond to or can tolerate oral medications and may have improvement in their symptoms with BOTOX® injections in the bladder or InterStim® Therapy.
What will I be asked to do?
Urodynamics, a routine bladder evaluation, will be required prior to study enrollment. Routine clinical tests and a three-day bladder diary (a daily record of your voids and episodes of urinary leakage) will be completed to determine if you are eligible.
If you are eligible, you will be randomly assigned, like a flip of the coin, to either receive Botox or InterStim® Therapy. Your study participation will last up to two years and will include in-person visits, telephone calls, completion of symptoms questionnaires, and 3-day bladder diaries. You will receive financial compensation for completed visits, calls, questionnaires and diaries.
What happens to the information collected about me?
All research information will be treated confidentially.All of your study forms will be assigned a number, not your name.
Can I drop out of the study once I have begun?
Yes. Participation in the study is completely voluntary, and you may remove yourself from the study at any point. If you decide to drop out of the study, medical care will continue to be provided to you if you would like.
What will the study cost me?
There are no additional costs to you for study procedures while participating in this study. Any medical care outside of the study required for you will be charged to you or your insurance in the usual way.
What is the Pelvic Floor Disorders Network?
The Pelvic Floor Disorders Network (PFDN) is a team of doctors and researchers from eight clinical research centers around the country funded by the National Institutes of Health to improve the level of knowledge about pelvic floor disorders such as overactive bladder. Through research studies, the team will be able to identify the most effective ways to care for women. Women & Infants Hospital is proud to be a member of the PFDN.
The doctors participating from the Division of Urogynecology and Reconstructive Pelvic Surgery at Women & Infants Hospital include:
Deborah Myers, MD, Principal Investigator
Cassandra Carberry, MD
Brittany Star Hampton, MD
Charles Rardin, MD
Vivian Sung, MD, MPH
Kyle Wohlrab, MD
For more information
If you would like more information about the ROSETTA study or if you are interested in participating, please call Ann Meers, RN, research coordinator, at (401) 276-7869, email her at firstname.lastname@example.org. For information about the Pelvic Floor Disorders Network, visit www.pfdn.org.