Evidence map›Paper›PMID 22453267›Full record

Trial reportFemale pelvic medicine & reconstructive surgery

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.

Lekha S Hota, Katherine Hanaway, Michele R Hacker, Anthony Disciullo, Eman Elkadry, Patricia Dramitinos, Alexander Shapiro, Tanaz Ferzandi, Peter L Rosenblatt

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Female pelvic medicine & reconstructive surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2017
    Pooled it
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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

9 authors.

Lekha S HotaDepartment of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA, USA. lhota@mah.harvard.edu
Katherine Hanaway
Michele R Hacker
Anthony Disciullo
Eman Elkadry
Patricia Dramitinos
Alexander Shapiro
Tanaz Ferzandi
Peter L Rosenblatt

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
NCATS NIH HHS UL1 TR000170NCRR NIH HHS UL1 RR025758
6 · The paper itself

Abstract

objectivesThis study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).

methodsThis was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.

resultsForty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3-16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5-128.0) at 12 weeks and 3.5 (95% CI, 1.1-11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).

conclusionsThe TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.

Indexed as

Suburethral SlingsFemaleFollow-Up StudiesHumansIntention to Treat AnalysisMiddle AgedPostoperative PainProsthesis FailureProsthesis ImplantationQuality of LifeTreatment OutcomeUrinary Incontinence, Stress

Identifiers

PMID22453267
PMCPMC3712515

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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.