Evidence map›Paper›PMID 27453154›Full record

Trial reportNeurogastroenterology and motility2017

Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol.

A D Markland, J E Jelovsek, W E Whitehead, D K Newman, U U Andy, K Dyer, I Harm-Ernandes, S Cichowski, J McCormick, C Rardin and 4 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 24 citations in OpenAlex.

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  11. Biofeedback for Pelvic Floor Disorders.Clinics in colon and rectal surgery · 2021
    Review
  12. Article
  13. Pelvic floor rehabilitation for defecation disorders.Techniques in coloproctology · 2019
    Review
  14. Review
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

14 authors at 11 institutions in 1 country.

A D MarklandDivision of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
J E JelovsekObstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA.
W E WhiteheadDivision of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
D K NewmanDivision of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
U U AndyDepartment of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
K DyerDepartment of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA, USA.
I Harm-ErnandesDepartment of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
S CichowskiDepartments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
J McCormickDivision of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
C RardinDepartment of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA.
G SutkinDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
A ShafferRTI International, Research Triangle Park, NC, USA.
S MeikleThe Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Pelvic Floor Disorders Network
Geriatric Research Education and Clinical Center · USUniversity of Pennsylvania · USBrown University · USCleveland Clinic · USDuke Medical Center · USKaiser Permanente San Diego Medical Center · USNational Institutes of Health · USRTI International · USUniversity of New Mexico · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh Medical Center · 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
The Cleveland Clinic Clinical SiteU10HD054215 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI BARBER, MATTHEW D · 2006 to 2015
$3.2M
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 Sites (U10)U10HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI ARYA, LILY A · 2011 to 2015
$1.7M
Pittsburgh Pelvic Floor Research ProgramU10HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2011 to 2015
$1.6M
RCT of Hypnotherapy vs Tpolterodine for OAB: Voiding and Brain Activation ChangesU10HD069025 · NICHD · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROGERS, REBECCA GLENN · 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 U01 HD069031NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD054215NICHD NIH HHS U10 HD069006NICHD NIH HHS U10 HD069010NICHD NIH HHS U10 HD069025NICHD NIH HHS U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD054215NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010NIDDK NIH HHS R21 DK096201
6 · The paper itself

Abstract

backgroundStandardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI.

methodsIn a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. KEY

resultsTwenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. CONCLUSIONS & INFERENCES: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.

Indexed as

Biofeedback, PsychologyCognitive Behavioral TherapyFecal IncontinenceFemaleHumansManometryTreatment Outcomeanal sphincter exercisesanorectal manometryfactorial designfecal incontinencemanometry-assisted biofeedbackpelvic floor disordersrandomized placebo-controlled trialtreatment fidelityurge resistance training

Identifiers

PMID27453154
PMCPMC5198255
OpenAlexW2506313215

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.