Three main advantages

In comparison with the artificial sphincter, the mesh implant allows spontaneous micturition, there is no mechanical action required by the patient to open and close the urethra. "That is the biggest advantage, especially as we are often dealing with older individuals who may forget to manipulate the system due to their old age".

The second advantage is that the TOM-Sling is associated with fewer complications and less mechanical failures than the artificial sphincter. "It is generally acknowledged that the artificial sphincter needs to be replaced after 8 years on average: the cuff compresses the urethra every day and this can damage the surrounding tissues resulting in leakages etc. In principle, the TOM-Sling does not need to be replaced. But whether we are dealing with the artificial sphincter or our mesh compression system, over time there can be a reduction in efficiency, especially for patients who were suffering from total incontinence. Nevertheless, this reduction generally remains satisfactory".

In case of total deterioration, we can insert a second mesh, just as it is possible to insert a second artificial sphincter when the existing one no longer works. After failure of a mesh an artificial sphincter can also be implanted and vice versa.

Another advantage is the price. "An artificial sphincter is very expensive, around 5000 euros, and the mesh’s cost around 1500 to 2000 euros. I do not yet know the definitive prices but they are lower than the competition".

The TOM-Sling has been on the market for several days but its cost is not reimbursed. "That will be a difficult step in the current economic context but, given the results and the price, we can hope that the decision-makers will be sensitive to the advantages of the mesh device", considers Jean de Leval.

Small disadvantages

There are few disadvantages to the TOM-Sling, considers the urologist. There are only three and they are relatively rare. "There can be problems of retention: not being able to urinate in the beginning or not being able to urinate for several days or urination may be difficult. For about one patient in six, it will be necessary to reinsert a catheter: instead of removing this after 2 days, we remove it after 8 days. We also encountered a 1 to 2% infection rate at the site of the intervention and sometimes perineal pain (with some numbness), which most often disappears after a few days or weeks. There can be more severe pain, especially in patients that have undergone radiation therapy because the tissues are harder and it is necessary to pull harder etc.” Pain is a common factor to all surgery in this area I believe. With the artificial sphincter, there is not the same level of pain because in turn, there is not the same level of compression. In this case the device opens and closes the urethra without compressing the structures containing blood vessels and nerves".

Word of mouth

In Belgium, 300 to 450 patients could benefit from this technique every year. "Our aim is not to carry out 1000 operations per year; we want our system to become viewed as something extremely interesting and positive for the patient. That is our main objective. Following on from this, we would like our technique to be developed elsewhere. We have to act in such a way that urologists show an interest in the technique and that they come to us to receive suitable training. We are a university and we want to train doctors and heal patients. To this end, the Swiss experience is interesting because it has been carried out with other doctors who were delighted with its performance. People are coming from all over to be treated and the trend is increasing. We are therefore confident with regard to the quality of our device", concludes Jean de Leval.

Recently, the TOM-Sling was officially presented to all the academic professors of the Belgian universities. In the month of June, it will be the turn of urologists from other countries to be duly informed. The TOM-Sling will be largely available to allow men who have had an operation on the prostate to regain normal continence.