Evidence map›Paper›PMID 34242627›Full record

Trial reportAmerican journal of obstetrics and gynecology2021

Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

Heidi S Harvie, Vivian W Sung, Simon J Neuwahl, Amanda A Honeycutt, Isuzu Meyer, Christopher J Chermansky, Shawn Menefee, Whitney K Hendrickson, Gena C Dunivan, Donna Mazloomdoost and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Heidi S HarvieDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA. Electronic address: hharvie@pennmedicine.upenn.edu.
Vivian W SungDepartment of Obstetrics and Gynecology, Women and Infants Hospital, the Warren Alpert Medical School of Brown University, Providence, RI.
Simon J NeuwahlSocial, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Amanda A HoneycuttSocial, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Isuzu MeyerDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
Christopher J ChermanskyDepartment of Urology, University of Pittsburgh, Pittsburgh, PA.
Shawn MenefeeDepartment of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA.
Whitney K HendricksonDepartment of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
Gena C DunivanDepartment of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.
Donna MazloomdoostEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.
Sarah J BassSocial, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Marie G GantzSocial, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network
RTI International · USBrown University · USDuke Medical Center · USKaiser Permanente San Diego Medical Center · USNational Institutes of Health · USUniversity of Alabama at Birmingham · 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
Pelvic Floor Disorders Network Data Coordinating Center (U01)U01HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI GANTZ, MARIE G · 2011 to 2015
$19.7M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
UNC Pelvic Floor Disorders Research CollaborativeU10HD041267 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VISCO, ANTHONY G · 2001 to 2015
$5.0M
Pelvic Floor Disorders NetworkU10HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LUKACZ, EMILY S. · 2006 to 2015
$3.3M
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
Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical SiteUG1HD041267 · NICHD · DUKE UNIVERSITY · PI NAZEMA Y SIDDIQUI · 2016 to 2026
$2.8M
Pelvic Floor Disorders Network Clinical Sites (U10)U10HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI ARYA, LILY A · 2011 to 2015
$1.7M
Brown/WIH Pelvic Floor Disorders Network SiteU10HD069013 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI SUNG, VIVIAN W · 2011 to 2015
$1.6M
Pittsburgh Pelvic Floor Research ProgramU10HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2011 to 2015
$1.6M
NICHD NIH HHS U01 HD069031NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD069006NICHD NIH HHS U10 HD069010NICHD NIH HHS U10 HD069013NICHD NIH HHS U10 HD069025NICHD NIH HHS U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD041267NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010NICHD NIH HHS UG1 HD069013
6 · The paper itself

Abstract

backgroundUrinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking.

objectiveCost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY

designThis prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile.

resultsThe costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years.

conclusionOverall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

Indexed as

Cognitive Behavioral TherapyCombined Modality TherapyCost-Benefit AnalysisFemaleHumansMiddle AgedPhysical Therapy ModalitiesProspective StudiesQuality of LifeSuburethral SlingsSurveys and QuestionnairesTreatment OutcomeUrinary Incontinencebehavioral therapyEuroQol-5 Dimensionmidurethral slingmixed urinary incontinencepelvic floor muscle therapyquality-adjusted life-yearsstress urinary incontinenceurgency urinary incontinence

Identifiers

PMID34242627
PMCPMC8633051
OpenAlexW3178644348

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Registered trials

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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.