| 1. |
- Andrada Hamar, Maria, et al.
(författare)
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Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur
- 2011
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Ingår i: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 22:7, s. 781-787
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesis: The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.Methods: We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.Results: No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).Conclusions: In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
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| 2. |
- Andrada Hamer, Maria, et al.
(författare)
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One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.
- 2012
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462.
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. RESULTS: No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). CONCLUSION: The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.
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| 3. |
- Andrada, Maria, et al.
(författare)
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Preoperative urethral parameters at rest and objective cure following laparoscopic colposuspension.
- 2010
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462. ; 21:3, s. 331-336
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION AND HYPOTHESIS: The aim of this study is to investigate associations between preoperative resting urethral parameters and objective outcome of laparoscopic colposuspension. METHODS: Data from 219 stress incontinent women who underwent laparoscopic colposuspension, with leakage at standardized pad test repeated after surgery, were collected. Associations between objective cure and preoperative maximum urethral closure pressure, functional urethral length, and continence area were analyzed using receiving operator characteristics curves. The level for 75% cure for each parameter was identified. RESULTS: All parameters were positively associated with cure. Continence area showed the strongest association. No cut-off values for prediction of failure were found. Women having levels equal or higher than the "75% cure level" for all urethral parameters had a cure rate of 88% compared with 55% for women with all parameters lower than this level. CONCLUSIONS: A combination of the urethral parameters may be useful for identifying patients with excellent chance for cure after colposuspension. Further studies are needed on continence area.
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| 4. |
- Larsson, Per-Goran, et al.
(författare)
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A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure
- 2010
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462. ; 21:9, s. 1175-1177
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Tidskriftsartikel (refereegranskat)abstract
- We report a serious complication following a TVT-Secur procedure due to injury of the corona mortis requiring a surgical intervention for removal of 1 l of clotted blood from the space of Retzius. The corona mortis is an anomaly of the vessel combining the obturator and epigastric arteries passing over the superior pubic ramus, well known to hernia and orthopedic surgeons but probably less well known to gynecological surgeons.
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