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JU INSIGHT Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: ROSETTA Trial
By: Bradley C. Gill, MD, MS, Cleveland Clinic, Ohio; Sonia Thomas, DrPH, RTI International, Research Triangle Park, North Carolina; Lindsey Barden, BSPH, RTI International, Research Triangle Park, North Carolina; J. Eric Jelovsek, MD, MMEd, MSDS, Duke University, Durham, North Carolina; Isuzu Meyer, MD, MSPH, University of Alabama at Birmingham; Christopher Chermansky, MD, University of Pittsburgh, Magee-Womens Research Institute, Pennsylvania; Yuko M. Komesu, MD, University of New Mexico, Albuquerque; Shawn Menefee, MD, Kaiser Permanente San Diego, California; Deborah Myers, MD, Brown University, Providence, Rhode Island; Ariana L. Smith, MD, University of Pennsylvania, Philadelphia; Donna Mazloomdoost, MD, National Institutes of Health, Bethesda, Maryland; Cindy L. Amundsen, MD, Duke University, Durham, North Carolina, For the NICHD Pelvic Floor Disorders Network | Posted on: 30 Aug 2023
Gill BC, Thomas S, Barden L, et al. Intraoperative predictors of sacral neuromodulation implantation and treatment response: results from the ROSETTA trial. J Urol. 2023;210(2):331-340.
Study Need and Importance
This study addressed a knowledge gap in the use of sacral neuromodulation as a treatment for overactive bladder—intraoperative predictors of treatment success. This substudy of the randomized, prospective, multicenter ROSETTA trial focused upon analyzing motor and sensory responses and how they related to stimulus settings during lead placement. The aim was to determine if specific combinations of responses and device settings were associated with successful test stimulation (permanent device implantation) and improved therapeutic response. The goal was to use these data to provide guidance for implanters on what to target when placing leads to optimize results for patients.
What We Found
We found getting the best motor responses on the distal-most electrode (number 0), rather than the proximal-most electrode (number 3), was associated with better outcomes—both for test stimulation and therapeutic response. This is likely evidence of the lead coursing along the anatomical path of the nerve, which indicates better lead placement that can facilitate better outcomes. As electrode 3 is most proximal and likely constrained within the sacral foramen, in close proximity to the nerve, relying upon responses from this electrode may lead to suboptimal results as the remainder of the electrode may course away from the nerve (see Figure).
Limitations
This study was limited by a relatively low number of negative events (test stimulation/stage 1 failures) that decreased the ability to determine predictors of outcomes, as well as the use of subjectively quantified intraoperative patient responses and analog pulse generator settings that introduced additional variability into measurements.
Interpretation for Patient Care
This study found having better stimulation responses at the end of the implanted lead (electrode 0) was associated with better outcomes for overactive bladder patients treated with sacral neuromodulation.
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