Researchers from Liege have developed a new surgical device allowing the implantation of a mesh for compressing the bulbar urethra in order to treat moderate to severe stress urinary incontinence occurring in males after complete removal of the prostate. After 8 years of testing, the TOM-Sling kit is today available on the market. It is an effective alternative in cases where conservative measures have failed.
Problems of incontinence and the mechanisms responsible for these incontinence problems are the full-time preoccupation of Prof. Jean de Leval, a Urologist at the University Hospital of Liege and an Emeritus Professor of Urology at the University of Liege. Since the beginning of his career he has devoted much time and effort to understand the problem and to find innovative technical answers. Consequently, in 1982, his doctoral thesis contributed to the study of the the striated urethral sphincter in the mechanisms of continence both in males and females.
There are two types of urinary incontinence: stress urinary incontinence (occurring during laughing, coughing, sneezing, walking, running…) and urge incontinence. The latter is as frequent as the former, but it is more disabling: the bladder contracts too quickly, too early and to the extent that the individual is not able to control it.
In 1995, a Swedish Gynaecologist, Ulf Ulmsten, developed a technique for treating stress urinary incontinence in women. It involved the insertion of a small polypropylene mesh implant by means of the vagina known as TVT (Tension-free Vaginal Tape), which supports the urethra during stress in order to prevent urine leakages. This technique uses a curved metallic instrument passed behind the pubic bone. The results have been excellent but there is a risk of bleeding and perforation of the bladder. The integrity of the bladder must be checked at the end of the surgical procedure with a cystoscopy.
In 2001, in order to avoid the blind passage behind the pubis, a French Urologist, Emmanuel Delorme has proposed a transobturator route (2 natural orifices within pelvic bones) from outside (thigh) -in (vagina). Complications specifically associated with the retropubic passage of TVT were largely reduced but the mesh implant used generated complications due to vaginal eroion and infection.
In 2002, under the light of his works on the mechanisms responsible for urinary continence and following many dissections conducted together with Prof. Pierre Bonnet (Professor of Anatomy at the University of Liege), Jean de Leval suggested an inside (vagina) -out (thigh) route. He described a novel technique using specific instruments. The trajectory of the device in tissues is consistent and reproducible with a minimal risk of causing damage to surrounding neuro-vascular structures.
Better and better
This novel technique required a new instrumentation. "We manufactured these instruments ourselves at the University Hospital of Liège in 2002-2003”, explains the urologist. I then completed the prototypes thanks to a partnership of a company called Medi-Line, located in the Sart Tilman Science Park. Medi-Line helped us to insert a plastic element to a metal element thereby facilitating the passage of the mesh implant".
Patented by the University of Liege and the University Hospital of Liege, the TVT-O device was marketed by Gynecare, a subsidiary of Johnson&Johnson, in January 2004. At present, it is the most widely implanted transobturator tape in the world for the treatment of female stress urinary incontinence. Professor de Leval did not stop there and, over time, made various improvements to the system so that now there is also the TVT-ABBREVO, a TVT inserted by the transobturator route but with a shorter mesh implant (on the market since 2010), and the TVT-EXACT, which is inserted via a retropubic route (like the first TVTs developed by Prof. Ulmsten), but with more refined and suitable instruments.
In summary, the TVT-O, TVT-ABBREVO and TVT-EXACT are made of the same mesh material and only the methods of insertion are different. "When developing methods to insert the mesh implant, we sought and found the safest and least traumatic ways possible for patients. And we know today that these polypropylene-based products yield the best long-term outcomes”.