TVT Secur™ : de plus en plus minimal invasif. Étude préliminaire prospective sur 110 cas

Debodinance, P.; Lagrange, É.; Amblard, J.; Lenoble, Clarisse; Lucot, Jean-Philippe; Villet, R.; Cosson, Michel; Jacquetin, B.

doi:10.1016/j.jgyn.2008.01.008

Cited by 44 publications

(23 citation statements)

References 7 publications

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“…The mean (median, range) follow-up was 15 (14,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) months. At the last assessment 75 patients (71%) were cured and 15 (14%) were improved, corresponding to an overall success rate of 85%, with the procedure failing in 16 (15%).…”

Section: Resultsmentioning

confidence: 99%

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Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

et al. 2009

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symptoms, incontinence cure rate and the King's Health Questionnaire (KHQ) score were evaluated. RESULTSThe operative duration was 12 min; the mean pain score was 2.3 and only one patient had transient voiding difficulties. After a mean follow-up of 15 months, 71% of the patients were dry and 14% improved. The KHQ scores decreased significantly for most subscores. Urgency appeared de novo in six patients (5.6%), and vaginal erosion required one TVT-Secur explantation. CONCLUSIONThis study shows that TVT-Secur is a simple and safe treatment for female SUI, but before recommending this sling as a first choice for treating SUI, TVT-Secur must pass the test of time and comparative studies with conventional slings.

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Section: Resultsmentioning

confidence: 99%

“…Although cystoscopy was not used systematically in the present study during surgery, there is a report of bladder injury during TVT-Secur placement [18]. Thus, cystoscopy might be recommended at the end of the procedure, especially when surgeons are gaining experience with the technique.…”

Section: Discussionmentioning

confidence: 95%

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

et al. 2009

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“…Il insiste sur la nécessité d'un apprentissage méticuleux de la technique qui lui a permis d'améliorer sa technique de pose. Nous avons publié une série prospective de 110 patientes[18], où nous rapportions 70,4 % de guérison, 24,1 % d'amélioration et 5,5 % d'échec à deux mois. Les complications étaient du même ordre que pour le MiniArc TM .…”

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MiniArc™ : résultats à court terme d’une série prospective de 72 cas

Debodinance¹,

Delporte²

2009

Journal de Gynécologie Obstétrique et Biologie de la Reproducti

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“…Stage 1 -Promising reports, n= 4 [36][37][38][39] McKinlay described the first promising reports of a new innovation as generally being of poor methodological quality, and this was the case for the initial reports of TVT Secur.…”

Section: Resultsmentioning

confidence: 99%

The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model

Ross

Robert

Ducey

2015

Health Policy and Technology

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Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wished to examine whether the model fits a modern device life cycle, and to comment on device manufacturers' influence on the life cycle. We chose to study the complete life cycle of TVT Secur, a mesh kit for surgical treatment of stress urinary incontinence in women, from its marketing in 2006 to device discontinuation for commercial reasons in March 2013. Methods: A PubMed review was undertaken to identify all published literature related to TVT Secur from 2006 to November 2014. Each publication was classified according to McKinlay's seven stages.Results: Eighty-three relevant publications from 22 countries were identified: 4 promising reports, 1 professional adoption, 0 third-party endorsement, 34 standard procedure, 19 randomised controlled trials (RCTs) from 2010 and mainly describing comparisons with other TVT family members), 0 professional denunciation of RCT findings, and 4 erosion and discreditation. Conclusions:McKinlay's seven stages model was useful to describe TVT Secur's truncated life cycle. TVT Secur, fully approved and licensed according to all jurisdictional requirements, generated many descriptive cohort studies but more rigorous RCT evidence appeared only half way through its life cycle. Device discontinuation meant that the stage of erosion and discreditation described by McKinlay occurred after TVT Secur was no longer available.

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TVT Secur™ : de plus en plus minimal invasif. Étude préliminaire prospective sur 110 cas

Cited by 44 publications

References 7 publications

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

MiniArc™ : résultats à court terme d’une série prospective de 72 cas

The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model

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