Trial reportInternational urogynecology journal2015
Contasure-Needleless® single incision sling compared with transobturator TVT-O® for the treatment of stress urinary incontinence: long-term results.
Trial report in International urogynecology journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results.International urogynecology journal · 2018Trial
- A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence.International urogynecology journal · 2018Trial
- A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.International urogynecology journal · 2016Trial
- Review
- Contasure-needleless® compared with Monarc® for the treatment of stress urinary incontinence.International urogynecology journal · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThis study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up .
methodsNon-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) .
resultsTwo hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O® or C-NDL® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL® group (84.7%) had a negative stress test, compared with 54 women (88.9%) in the TVT-O® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7% of patients in the C-NDL® group and 95.4% of patients in the TVT-O® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O® group. The degree of satisfaction was not statistically significant between the two groups.
conclusionsThe outcomes for the C-NDL® group were similar to those of the TVT-O® group, adding the concept of "single incision tape" to the tension-free sling option.
Indexed as
Identifiers
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Registered trials
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.