Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial

J Urol. 2023 Aug;210(2):331-340. doi: 10.1097/JU.0000000000003498. Epub 2023 Apr 26.

Abstract

Purpose: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence.

Materials and methods: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression.

Results: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response.

Conclusions: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Keywords: implantable neurostimulators; overactive; percutaneous electrical neuromodulation; urinary bladder.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Electric Stimulation Therapy* / methods
  • Female
  • Humans
  • Lumbosacral Plexus
  • Prospective Studies
  • Sacrum / surgery
  • Transcutaneous Electric Nerve Stimulation* / methods
  • Treatment Outcome
  • Urinary Bladder, Overactive* / therapy
  • Urinary Incontinence* / therapy
  • Urinary Incontinence, Urge / surgery