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Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia LU ; Etén-Bergqvist, Christina and Persson, Jan LU (2011) In International Urogynecology Journal 22. p.781-787
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... (More)
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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
International Urogynecology Journal
volume
22
pages
781 - 787
publisher
Springer
external identifiers
  • wos:000291490100004
  • pmid:21499755
  • scopus:80052428019
ISSN
1433-3023
DOI
10.1007/s00192-011-1381-8
language
English
LU publication?
yes
id
9aa9901c-021c-4ad0-a569-2df4ebd47648 (old id 1936992)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/21499755?dopt=Abstract
date added to LUP
2011-05-02 14:49:55
date last changed
2017-08-06 04:44:05
@article{9aa9901c-021c-4ad0-a569-2df4ebd47648,
  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 &lt; 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.},
  author       = {Andrada Hamer, Maria and Larsson, Per-Göran and Teleman, Pia and Etén-Bergqvist, Christina and Persson, Jan},
  issn         = {1433-3023},
  language     = {eng},
  pages        = {781--787},
  publisher    = {Springer},
  series       = {International Urogynecology Journal},
  title        = {Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.},
  url          = {http://dx.doi.org/10.1007/s00192-011-1381-8},
  volume       = {22},
  year         = {2011},
}