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J Urol. 2019 Nov 18:101097JU0000000000000656. doi: 10.1097/JU.0000000000000656. [Epub ahead of print]

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

Author information

1
Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.
2
Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.
3
Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, North Carolina.
4
Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Diego, California.
5
Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.
6
Department of Obstetrics and Gynecology, University of New Mexico and Department of Women's Health, Dell Medical School, University of Texas, Austin, Texas.
7
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
8
Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
9
Department of Urology, University of Pittsburgh, Pennsylvania.
10
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

Abstract

PURPOSE:

Sacral neuromodulation and intradetrusor injection of onabotulinumtoxinA are therapies for refractory urgency-urinary incontinence. Sacral neuromodulation involves surgical implant of a device that can last 4-6 years, while onabotulinumtoxinA involves serial office injections. Objective was to assess cost-effectiveness of 2-stage implantation sacral neuromodulation versus 200 units onabotulinumtoxinA for the treatment of urgency-urinary incontinence.

MATERIAL AND METHODS:

Prospective economic evaluation concurrent with Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) randomized trial of 386 women with ≥ 6 urgency-urinary-incontinence episodes in 3-day diary. Analysis from healthcare system perspective, with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs in 2018 U.S. dollars. Effectiveness measured in quality-adjusted life-years (QALYs) and reductions in urgency-urinary-incontinence episodes/day. Generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.

RESULTS:

Two-year costs were higher for sacral neuromodulation versus onabotulinumtoxinA ($35,680 [95%CI $33,920-$37,440] versus $7,460 [95%CI $5,780-$9,150], p<0.01), persisting through 5 years ($36,550 [95%CI $34,787-$38,309] versus $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/day (-3.00 [95%CI -3.38 - -2.62] versus -3.12 [95%CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95%CI 1.34-1.44] versus 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/QALY at 2 years and $204,000/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 with 200 units onabotulinumtoxinA.

KEYWORDS:

OnabotulinumtoxinA; cost-effectiveness; sacral neuromodulation; urgency urinary incontinence

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