Evidence map›Paper›PMID 31738113›Full record

Trial reportThe Journal of urology2020

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

Heidi S Harvie, Cindy L Amundsen, Simon J Neuwahl, Amanda A Honeycutt, Emily S Lukacz, Vivian W Sung, Rebecca G Rogers, David Ellington, Cecile A Ferrando, Christopher J Chermansky and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Sacral neuromodulation therapy for urinary and defecatory disorders: experience in a Latin American public hospital.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2024
    Article
  10. Article
  11. Review
  12. Article
  13. Sacral neuromodulation: troubleshooting needle placement.International urogynecology journal · 2021
    Article
  14. Review
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 1 country.

Heidi S HarvieDepartment of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.
Cindy L AmundsenDepartment of Obstetrics and Gynecology, Duke University, Durham.
Simon J NeuwahlSocial, Statistical and Environmental Sciences Group, RTI International, Research Triangle Park, North Carolina.
Amanda A HoneycuttSocial, Statistical and Environmental Sciences Group, RTI International, Research Triangle Park, North Carolina.
Emily S LukaczDepartment of Obstetrics, Gynecology & Reproductive Sciences, University of California San Diego, La Jolla, California.
Vivian W SungDepartment of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.
Rebecca G RogersDepartment of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico.
David EllingtonDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
Cecile A FerrandoObstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
Christopher J ChermanskyDepartment of Urology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Donna MazloomdoostEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Sonia ThomasSocial, Statistical and Environmental Sciences Group, RTI International, Research Triangle Park, North Carolina.
RTI International · USBrown University · USCleveland Clinic · USDuke University · USNational Institutes of Health · USUniversity of Alabama at Birmingham · USUniversity of California, San Diego · USUniversity of New Mexico · USUniversity of Pennsylvania · USUniversity of Pittsburgh · US

Funding

Pelvic Floor Disorders Network Data Coordinating Center Administrative Supplement: ODSS CDE FundingU24HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MARIE G GANTZ · 2016 to 2026
$35.8M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
Brown/WIH Pelvic Floor Disorders Network Site (UG1)UG1HD069013 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI Vivian W Sung · 2016 to 2026
$3.1M
Pelvic Floor Disorders Network Clinical Sites (UG1)UG1HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Heidi S Harvie · 2016 to 2026
$3.0M
Pelvic Floor Disorders Network Clinical Site Application: The San Diego PelvicFloor ConsortiumUG1HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EMILY S. LUKACZ, Shawn A Menefee · 2016 to 2026
$2.9M
Pittsburgh Pelvic Floor Research ProgramU10HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2011 to 2015
$1.6M
Pittsburgh Pelvic Floor Research ProgramUG1HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2016 to 2021
$1.5M
University of Alabama at Birmingham: Pelvic Floor Disorders NetworkUG1HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2016 to 2021
$1.4M
NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD069006NICHD NIH HHS U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010NICHD NIH HHS UG1 HD069013
6 · The paper itself

Abstract

purposeSacral 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

methodsProspective 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.

resultsTwo-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.

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

Indexed as

Health Care CostsBotulinum Toxins, Type ACost-Benefit AnalysisDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansLumbosacral PlexusMaleMiddle AgedProspective StudiesTime FactorsTranscutaneous Electric Nerve StimulationTreatment OutcomeUrinary Incontinence, UrgeUrinationBotulinum Toxins, Type Aonabotulinum toxin Abotulinum toxinscost-benefit analysistranscutaneous electric nerve stimulationtype Aurgeurinary incontinence

Identifiers

PMID31738113
PMCPMC7204548
OpenAlexW2987462114

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.