Evidence map›Paper›PMID 28971224›Full record

Trial reportInternational urogynecology journal2018

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

Claudia Cristina Palos, Ana P Maturana, Frederico R Ghersel, Cesar E Fernandes, Emerson Oliveira

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International urogynecology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. 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

5 authors at 2 institutions in 3 countries.

Claudia Cristina PalosDepartment of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Príncipe de Gales, 821 - Vila Príncipe de Gales, Santo André, SP, 09060-650, Brazil. claupalos@hotmail.com.ORCID http://orcid.org/0000-0001-5242-5762
Ana P MaturanaDepartment of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Príncipe de Gales, 821 - Vila Príncipe de Gales, Santo André, SP, 09060-650, Brazil.
Frederico R GherselDepartment of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Príncipe de Gales, 821 - Vila Príncipe de Gales, Santo André, SP, 09060-650, Brazil.
Cesar E FernandesDepartment of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Príncipe de Gales, 821 - Vila Príncipe de Gales, Santo André, SP, 09060-650, Brazil.
Emerson OliveiraDepartment of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Príncipe de Gales, 821 - Vila Príncipe de Gales, Santo André, SP, 09060-650, Brazil.
Faculdade de Medicina do ABC · BRSwiss Paraplegic Center · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

methodsThis was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

resultsEighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

conclusionsThe cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

Indexed as

Suburethral SlingsFemaleHumansIntention to Treat AnalysisMiddle AgedPostoperative ComplicationsProspective StudiesQuality of LifeTreatment OutcomeUrinary Incontinence, StressUrinary RetentionMidurethral slingNoninferiority analysisQuality of lifeRetropubic slingStress urinary incontinenceTransobturator sling

Identifiers

PMID28971224
OpenAlexW2761606135

What OpenQuestion holds

Textmetadata
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.