TVT-Secur for the treatment of female stress urinary incontinence: a 24-month follow-up retrospective study

Tommaselli, Giovanni A.; Carlo, Costantino Di; Formisano, Carmen; Fabozzi, Annamaria; Nappi, Carmine

doi:10.1007/s00404-012-2322-6

Cited by 5 publications

(2 citation statements)

References 38 publications

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“…Short- and midterm reports on Mini-Arc have, on the majority, been consistent with the initial results of this series [6, 7] and comparable to conventional MUS [20, 21], with a low morbidity profile [20, 21]. …”

Section: Resultssupporting

confidence: 83%

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Mini-Arc for the Treatment of Female Stress Urinary Incontinence: Long-Term Prospective Evaluation by Patient Reported Outcomes

et al. 2014

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Single-incision slings were introduced in the surgical treatment of female stress urinary incontinence (SUI) to lessen the morbidity associated with traditional midurethral slings. However, long-term reports on patient satisfaction are still scarce. This study describes the outcome of women treated with Mini-Arc at a mean follow-up of 45 months. In a previous report on 105 women with 15-month mean follow-up, 84 (80%) were found cured and 12 (11%) improved. Now, with a mean follow-up of 45 months, cured/improved patients were reassessed by telephone and completed Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S), rated their improvement in a 0–100 scale, and answered if they would recommend the procedure. At 45-month follow-up, 73 women cured/improved were available for evaluation. Over 80% of the cured patients rated the improvement of SUI by the PGI-I as “very much better” or “much better,” reported their urinary tract condition to be “normal” on PGI-S, and described their improvement >70%. Ninety percent would recommend this procedure to a friend. The improved-patient population is very small (n = 7). This study shows that the majority of patients cured/improved after Mini-Arc placement maintain a high degree of satisfaction at a long-term evaluation.

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Section: Resultssupporting

confidence: 83%

“…These SIS outcomes are comparable with conventional MUS at short-term follow-up [3–5]. Although sparse, two-year follow-up studies are available and seem to maintain steady success rates over this time [6, 7]. Longer follow-up time reports are needed, to ensure that, in the long run, these SIS offer constant success rates.…”

Section: Introductionmentioning

confidence: 95%

Mini-Arc for the Treatment of Female Stress Urinary Incontinence: Long-Term Prospective Evaluation by Patient Reported Outcomes

et al. 2014

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Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results

et al. 2014

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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 for the treatment of female stress urinary incontinence: a 24-month follow-up retrospective study

Abstract: TVT-Secur seems to be an effective and safe procedure for stress urinary incontinence.

Cited by 5 publications

References 38 publications

Mini-Arc for the Treatment of Female Stress Urinary Incontinence: Long-Term Prospective Evaluation by Patient Reported Outcomes

Mini-Arc for the Treatment of Female Stress Urinary Incontinence: Long-Term Prospective Evaluation by Patient Reported Outcomes

Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results

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

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