Evidence map›Paper›PMID 31895722›Full record

Trial reportThe American journal of gastroenterology2020

Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.

Holly E Richter, J E Jelovsek, P Iyer, R G Rogers, I Meyer, D K Newman, M S Bradley, I Harm-Ernandes, K Y Dyer, K Wohlrab and 3 more

Erratum issuedOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Faecal incontinence in adults.Nature reviews. Disease primers · 2022
    Review
  6. Personality of patients with fecal incontinence.International journal of colorectal disease · 2021
    Observational
  7. Article
  8. Constipation and Fecal Incontinence in the Elderly.Current gastroenterology reports · 2020
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Holly E RichterDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
J E JelovsekDepartment of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio.
P IyerRTI International, Research Triangle Park, North Carolina.
R G RogersDell Medical School, Department of Obstetrics and Gynecology, University of Texas at Austin, Austin, Texas.
I MeyerDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
D K NewmanPerelman School of Medicine, Department of Urology, University Pennsylvania, Philadelphia, Pennsylvania.
M S BradleyDepartment of Obstetrics and Gynecology, University of Pittsburgh, Magee-Women's Research Institute, Pittsburgh, Pennsylvania.
I Harm-ErnandesDepartment of Physical Therapy and Occupational Therapy, Duke University, Durham, North Carolina.
K Y DyerDepartment of Obstetrics and Gynecology, Kaiser Permanente, San Diego, California.
K WohlrabDepartment of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.
D MazloomdoostEunice Kennedy Shriver NICHD, Bethesda, Maryland.
M G GantzRTI International, Research Triangle Park, North Carolina.
Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women's Health
RTI International · USUniversity of Alabama at Birmingham · USBrown University · USCleveland Clinic · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USKaiser Permanente San Diego Medical Center · USMagee-Womens Research Institute · USThe University of Texas at Austin · USUniversity of Pennsylvania · US

Funding

OB/GYN FACULTY RESEARCH CAREER DEVELOPMENT PROGRAMK12HD001258 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JENKINS, TODD R · 1999 to 2019
$5.6M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
Pelvic Floor Disorders Network Clinical Sites (UG1)UG1HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Heidi S Harvie · 2016 to 2026
$3.0M
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
NICHD NIH HHS K12 HD001258NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD069006NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010
6 · The paper itself

Abstract

objectiveTo identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI).

methodsWomen (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 × 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, ≥50% reduction in FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence.

resultsTreatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score. DISCUSSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI.

Indexed as

Patient Education as TopicAgedAntidiarrhealsBiofeedback, PsychologyCombined Modality TherapyExercise TherapyFecal IncontinenceFemaleHumansLoperamideManometryMedication AdherenceMiddle AgedMinimal Clinically Important DifferenceOverweightSeverity of Illness IndexAntidiarrhealsLoperamide

Identifiers

PMID31895722
PMCPMC7197976
OpenAlexW2998185828

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.