Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial

J Urol. 2020 May;203(5):969-977. doi: 10.1097/JU.0000000000000656. Epub 2019 Nov 18.


Purpose: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence.

Materials and methods: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.

Results: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years.

Conclusions: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Keywords: botulinum toxins; cost-benefit analysis; transcutaneous electric nerve stimulation; type A; urge; urinary incontinence.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Botulinum Toxins, Type A / administration & dosage
  • Botulinum Toxins, Type A / economics*
  • Cost-Benefit Analysis
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Health Care Costs*
  • Humans
  • Lumbosacral Plexus
  • Male
  • Middle Aged
  • Prospective Studies
  • Time Factors
  • Transcutaneous Electric Nerve Stimulation / economics*
  • Transcutaneous Electric Nerve Stimulation / methods
  • Treatment Outcome
  • Urinary Incontinence, Urge / economics
  • Urinary Incontinence, Urge / physiopathology
  • Urinary Incontinence, Urge / therapy*
  • Urination / physiology*


  • Botulinum Toxins, Type A
  • onabotulinum toxin A