Male urinary incontinence: a new surgical treatment

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”.

And for males?

Jean de Leval asked himself the question: Why not insert this type of mesh implant in males too?  In 2006, he presented a new system which made it possible to carry out the procedure on patients suffering from stress urinary incontinence after radical prostatectomy.

In males, stress urinary incontinence is quite frequent, especially in the case of prostate disease. On the other hand, males are less subject to stress incontinence than females: in males, stress incontinence occurs almost always only after prostate surgeries and in particular, for prostate cancer (radical prostatectomy). "Because there are a large number of operations I thought about trying to do something for these patients", he continues.

Today the preferred method of treating stress urinary incontinence after total removal of the prostate gland is the artificial urinary sphincter. The American Brantley Scott developed the best artificial sphincter system in the seventies and it is still used today.

"It involves the insertion of a small cuff around the urethra, which is connected to a small liquid-filled balloon and a small pump used to activate the system. This pump is located in the scrotum in males and in one of the labia in females, you press on it to open and close and to fill and empty the cuff".

Using a mesh implant to treat male incontinence was therefore considered, and currently there is a large variety of them. Unlike the procedure for females, one needs to apply a significant pressure to the mesh implant in order to have sufficient tension.

After several years of research, the team of Professors Jean de Leval and David Waltregny (head of the Urology Department of the University Hospital of Liege), developed a new system of bulbar urethra compression. The mesh implant and instruments were first manufactured by the University Hospital of Liege in the Department of Biomechanics. Late April 2014, the TOM-Sling (Trans Obturator Male-Sling), obtained the EC conformity marking, which is mandatory for launching a product on the market. It is manufactured and marketed by Medi-Line.

A simple and effective kit

The TOM-Sling is a urethral compression mesh device. The kit is composed of an insertable polypropylene mesh implant (a material which is well-tolerated by the body), two arms designed to ensure optimal positioning of the mesh, these two lateral arms are inserted via a transobturator route inside (under the urethra) -out (thigh root) through the obturator foramens, a pair of patented passers, a winged guide, a pair of flexible tubes, and a pair of pull-wires.

The surgical procedure and instruments that have been patented by the University Hospital of Liege through the University-Enterprises Interface make it possible to find the precise positioning and optimal tension for the mesh implant, which are essential factors for restoring continence. Only experienced urologist surgeons involved in the management of these specific urinary disorders and who have had a specific training in the TOM-Sling technique by their peers can obtain the kit.
The operation takes 45 to 60 minutes, under local or general anesthesia.

In case of total prostatectomy

The procedure is indicated for men suffering from disabling moderate to severe incontinence 12 months after total prostatectomy and for whom conservative measures have failed. It should be noted that around 10% of these patients will experience persistent stress urinary incontinence after one year. Among this group, around 30% will have severe incontinence and 70% will experience mild to moderate incontinence. The urologist explains, “During the first few months, we carry out physiotherapy, perineal reeducation, electro stimulation etc., and the patients are eventually proposed a surgical intervention. This is for those who have had their prostate removed completely: we remove the gland and the urinary channel that is located there". Several sphincters are involved in controlling urination: the bladder neck, the urethra and the striated sphincter. In case of radical prostatectomy, a portion of the sphincter mechanisms is removed.

The other frequent prostate operation consists in removing an adenoma (or benign prostate hyperplasia): "We leave the outer aspect of the prostate and we remove the inner “nucleus”, it is like an orange from which we remove the quarters leaving only the peel. Because the sphincters are less altered, there is less incontinence (1% after adenomectomy)". We can also use the TOM-Sling device to treat this type of incontinence but they are mainly intended for the treatment of post-radical prostatectomy incontinence.

Good results

The TOM-Sling has already been implanted in 350 patients at the University Hospital of Liège. The TOM-Sling procedure is minimally invasive and associated with a high success rate (85%). Even though Professor de Leval recognizes that it is difficult to appreciate the results because the situation varies greatly from one individual to another and with that, the interpretation of the results: “What constitutes severe or mild incontinence? Some patients are totally incontinent: everything passes into urine collectors or diapers. Others suffer from mild incontinence: a small pad is applied which is barely wet while others have to use two small or large protections per day".

It is considered that mild incontinence requires maximum two pads per day, moderate incontinence between two and five protections per day and more than five protections per day are required for severe incontinence.

For the TOM-Sling, the first results were published in 2008 in European Urology(1). Prof. de Leval also operated on a series of patients (30) in Geneva, with good results that are due to be published soon.

"In our results, we included all patients treated from the beginning and we did not exclude anyone: We have a 50% total cure rate for patients (0 pad per day) and 30% showing a large improvement, that is to say less than 2 or 1 protection per day. Patients who were losing all their urine and now only 10ml per day are delighted with the results. For patients who have undergone pelvic radiation therapy or with a history of stenosis at the level of the anastomosis between the urethra and the bladder, results are less favorable. If we exclude this two categories of patients, we get a 90% success rate", explains Jean de Leval.

During the studies, the indications got better defined: it is currently advised to treat any stenosis before proceeding with a surgical cure for incontinence. After radiation therapy, tissues are modified; they lose their flexibility and become hardened. It is then necessary to exert a lot of pressure on the prosthesis in order to achieve tension which often lessens afterwards. In this case it is preferable to implant an artificial sphincter which generates better results; but even in these patients, results are lower after radiation therapy.

Safe and precise

Today, the team from Liège has treated a series of patients with very good results and a low rate of complications. "There are two reasons for this”, explains Jean de Leval: “on one hand, we use a safe anatomical route because we know that by passing through the obturator foramens there is a very small risk of damaging neighbouring neurovascular structures, and on the other hand, a significant tension needs to be applied to the mesh to have sufficient support in order to cure stress urinary leakages".

Compression of the bulbar urethra should not prevent micturition; therefore tension must be appropriately applied. The team carried out pressure measurements during the operation. "This is very original”, he says, “We are almost the only ones to do this. In order to adapt the tension to each patient, we must make what we call ‘a urodynamic investigation’ during the operation. We measure the pressure at which leakage occurs and we measure a pressure profile at the level of the urethra. For example, if you cough a little, you may experience leakage. If you apply a little pressure on the abdomen, urine can also leak out: if you have leakage for a pressure of 30cm of water, we will apply a level of tension so that when straining, a pressure of more than 100cm of water would be required for leakage to occur".

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.

(1) European Urology 2008;54:1051-65 & 2012;61:608-15. See also Neurourology and Urodynamics 2009;28:687-8 & 2010;29:9