Tension-free vaginal tape (TVT) is a well-established surgical procedure for the treatment of female stress urinary incontinence (SUI) and TVT-Secur was designed to reduce the undesired complications and to minimize the operative procedure as much as possible.
To present the authors' experience in using the classic TVT and TVT-Secur and to evaluate and compare complications and short- and long-term results.
A retrospective study and analysis of 230 patients presented with SUI at King Abdulaziz University Hospital (KAUH) and United Doctor Hospital (UDH) from March 1, 2007 until July 3, 2010. Classical TVT and TVT-Secur with or without associated operation were performed. All patients were controlled at six months and complications, as well as objective results, have been reported. The study was approved by ethical committee of KAUH.
All patients with SUI admitted to KAUH and UDH for sub-urethral tape were analyzed (230 patients); 149 had classical TVT and 81 had TVT-Secur. Their age ranged from 30 years to 73 years with a mean of 49.8 years and std of 9.4. Their parity ranged from two to 15 with a mean of 6.2 and std of 2.4. One hundred eighty patients had SUI and 50 patients had mixed incontinence. The type of anesthesia used was general anesthesia in 69.6% (160) of cases and regional anesthesia in form of epidural or spine in 30.4% (70) of cases. Operative complications revealed a bladder perforation in 3.5% (eight) of cases and 2.2% had bleeding of more than 200 ml, and 53 patients which contribute to 23% had retention and required a catheter for 48 hours or more. After three months, it was observed that erosion of the mesh occurred in three cases. Fourteen cases (7%) continue to have SUI failure rate.
The classical TVT and TVT-Secur were found to be very effective, easy, and safe procedures and with excellent results.
[Show abstract][Hide abstract] ABSTRACT: 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. We suggest that careful premarket evaluation of safety and effectiveness might decrease the need for commercial discontinuation of devices, and that post-marketing evaluation is a crucial mechanism to protect patients from harm.
Health Policy and Technology 02/2015; 4(2). DOI:10.1016/j.hlpt.2015.02.008
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