Creating a gold standard surgical procedure: the development and implementation of TVT

Abstract

The last two decades have witnessed a launch of new surgical procedures, utilizing kits and synthetic materials, at a pace not formerly seen. Some launches have been preceded by thorough clinical documentation and others not. Any innovation, be it a theory or a treatment concept, is only fantasy until it has been tested and clinically documented.Within the field of surgical management of female stress urinary incontinence the presentation of the mid-urethral theory (a part of the integral theory [1]) implied a paradigm shift of understanding the mechanism of stress incontinence. The theory relied on discoveries and ideas presented between the 1950s and the 1980s by several clinicians such as Axel Ingelman-Sundberg [2], Robert F. Zacharin [3,4], and Ulf Ulmsten [5][6][7] just to mention a few. The theory was put into practice by a team led by Professor Ulf Ulmsten by developing a new minimally invasive, ambulatory, standardized surgical procedure to be named the tension-free vaginal tape (TVT) at the time of launch in Europe at the end of 1997 and in the USA at the end of 1998.Several modifications of a procedure were tested before arriving at the final one, which included the use of a monofilament polypropylene tape with a mesh structure and a pore size of> 75 μm. Once the procedure was finalized, the first prospective clinical trial was conducted at the Department of Obstetrics and Gynecology of the University Hospital of Uppsala, Sweden, the chairman of which was Professor Ulmsten. The trial included 75 primary cases of stress urinary incontinence and were followed for 24 months. The results published in 1996 were very encouraging [8] and prompted further prospective clinical trials conducted in normal clinical settings. At this stage it was decided to follow the same study protocol in all the trials to come.The pre-and postoperative evaluations were to include urodynamic testing, a cough stress test, a 24-h pad weighing test, a 2-day voiding diary, residual urine measurement, urine analysis, pelvic examination, and as a quality of life measure a visual analog scale (VAS) on the bother caused by urinary symptoms. It was also decided on the criteria of cure and improvement. To be regarded cured a patient should have a negative stress test and negative pad test, be continent in postoperative urodynamics, and score less than 10 on the VAS, where 0 represents no urinary problems whatsoever and 100 unbearable urinary symptoms. Improvement required a negative stress test, a significant reduction of leakage on the 24-h pad test, and a≥70 % improvement of the individual VAS score. All other cases were regarded as failures.A multicenter trial including six clinics in Finland and Sweden enrolled 130 primary cases of stress incontinence, who were followed for a minimum of 12 months, showed the same high rate of success as the initial trial. This study was published in 1998 [9], but the results were available to the investigators at the beginning of the year before. The results of trials with a followup of 4 years on wome...

Single-incision mini-sling for the treatment of female stress urinary incontinence: Is it actually inferior to transobturator vaginal tape and tension-free vaginal tape?

“…The most common complication at retropubic approach is urinary retention (17%–50%). [ 24 29 ] In de Tayrac's study,[ 49 ] urinary retention was reported in 13.3% of women after TOT and 25.8% of women after TVT. Similar to that, urinary retention in our study was present in 10,0% of women after TOT procedure, 10.1% after SIMS and at 13.7%of women after TVT procedure.…”

“…Standard operating techniques were used as described by Petros and Papadimitriou,[ 13 ] Ulmsten,[ 29 ] and Delorme. [ 30 31 ] The surgeons involved in this study had experience with all surgical the abovementioned techniques.…”

Carl Gustav Nilsson 1944–2015

“…He published more than 100 scientific papers and was supervisor for six theses. He was extremely involved both nationally and internationally in numerous organizations, especially within the urogynecology profession, including the International Urogynecological Association (IUGA) [2], and a member of the executive committee of the European Urogynaecological Association (EUGA) until his death, chairman of the Finnish Society of Medicine 2008-2009, and became an honorary member of the Finnish Gynaecological Society in 2009. Although he formally retired in 2012, he remained highly participatory in the assessment of modern surgical techniques within urogynecology.…”

The failed idea of a “gold standard”

“…The term Bgold standard^is used quite often in medicine [1,2]. It says that there is a standard that clinicians should follow and that this is the best standard available, backed by solid evidence and broad consensus.…”