Evidence map›Paper›PMID 24837493›Full record

Trial reportNeurogastroenterology and motility2014

Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

A Mellgren, K E Matzel, J Pollack, T Hull, M Bernstein, W Graf, Nasha Dx Study Group

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 3% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Constipation and Fecal Incontinence in the Elderly.Current gastroenterology reports · 2020
    Review
  9. Article
  10. Review
  11. Outcomes of GatekeeperTechniques in coloproctology · 2017
    Observational
  12. Fecal Incontinence: Epidemiology, Impact, and Treatment.Clinics in colon and rectal surgery · 2016
    Article
  13. Article
  14. Functional Anorectal Disorders.Gastroenterology · 2016
    Article
  15. Evidence-Based Update on Treatments of Fecal Incontinence in Women.Obstetrics and gynecology clinics of North America · 2016
    Review
  16. Observational
  17. Article
  18. Management of pelvic floor disorders: biofeedback and more.Current treatment options in gastroenterology · 2014
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 3 countries.

A MellgrenDivision of Colon & Rectal Surgery, University of Illinois, Chicago, IL, USA.
K E Matzel
J Pollack
T Hull
M Bernstein
W Graf
Nasha Dx Study Group
Cleveland Clinic · USDanderyds sjukhus · SEFriedrich-Alexander-Universität Erlangen-Nürnberg · DENYU Langone Health · USUniversity of Illinois Urbana-Champaign · USUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInjectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms.

methodsIn a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder50 ). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated. KEY

resultsSuccessful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort. CONCLUSIONS & INFERENCES: Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years.

Indexed as

AgedDextransFecal IncontinenceFemaleHumansHyaluronic AcidInjectionsMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeDextransHyaluronic AcidNASHA-Dx copolymerfecal incontinenceinjectable bulking agentsNASHA Dxnon-animal stabilized hyaluronic acid/dextranomer

Identifiers

PMID24837493
PMCPMC4371654
OpenAlexW2013399622

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.