Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this randomized, open-label, active-control trial is to compare the
effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral
neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary
incontinence. In addition, the study will evaluate select technical attributes of the
interventions as well as the effect of these two interventions on other lower urinary tract
and pelvic floor symptoms.
Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary
incontinence episodes over the 6-month follow-up period as compared to Botox A® injection.
A supplemental study investigates whether biological markers including those related to
inflammation and connective tissue remodeling change following treatments with Botox A® and
Interstim®.
Phase:
Phase 3
Details
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborators:
Brown University Duke University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Oregon Health and Science University RTI International The Cleveland Clinic University of Alabama at Birmingham University of California, San Diego University of New Mexico University of Pennsylvania University of Pittsburgh
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA