WO2006064063A1

WO2006064063A1 - Novel medical prosthesis and related uses thereof in the treatment of stress urinary incontinence

Info

Publication number: WO2006064063A1
Application number: PCT/ES2004/070108
Authority: WO
Inventors: Jorge Valle Gerhold; Agustin Camon Lasheras
Original assignee: Consejo Superior De Investigaciones Científicas
Priority date: 2003-12-17
Filing date: 2004-12-14
Publication date: 2006-06-22
Also published as: ES2237321A1; ES2237321B1

Abstract

The invention relates to a medical prosthesis which is intended for surgical implantation in humans, preferably in women with stress urinary incontinence. The inventive device comprises a serum bag which is placed around the urethra, with the ends thereof positioned inside the abdominal cavity. When pressure in the abdomen is increased, for example owing to a fit of coughing, said pressure is applied against the urethra, thereby occluding same and preventing the release of urine. The inventive prosthesis is advantageous in that it operates automatically without the user having to manipulate the device in order to urinate. In addition, the prosthesis only squeezes the urethra for a few seconds, thereby preventing the discomfort that is generated by devices that squeeze the urethra permanently. The inventive prosthesis, which is very simple and reliable, can be implanted within 30 minutes by means of a single incision in the vagina, such that the patient can be discharged from hospital after a few hours.

Description

TITLE

NEW MEDICAL PROSTHESIS AND ITS APPLICATIONS FOR THE TREATMENT OF URINARY INCONTINENCE OF EFFORT

SECTOR OF THE TECHNIQUE

Medicine and industry sector dedicated to the manufacture of devices, devices and auxiliary elements for medicine. Medical prosthesis to correct stress urinary incontinence.

STATE OF THE TECHNIQUE

Stress urinary incontinence is what occurs when the patient coughs, laughs, lifts weights or in the most severe cases simply when walking. At rest, the urethra with its striated sphincter has a higher pressure than urine in the bladder: in an adult sitting, the pressure in the abdomen is similar to that inside the bladder, about 20 cm of water above of the atmospheric pressure against about 50 cm of water inside the urethra, but when an effort is made as described, the pressure inside the bladder increases above 100 cm of water. In a healthy individual, this increase in abdominal pressure is transmitted to a sufficient portion of the urethra through the soft fatty tissues that surround it, thus compensating for occasional increases in bladder pressure and not leaking urine

(Miller E.R .: Bladder and urethra: An overview. Invest

Radiol 7: 280, 1972). It is known, however, that for various reasons and especially in women, it is very common for the urethra to move into the vagina, fleeing from the area where abdominal pressure changes are transmitted. There is then an increase in bladder pressure that is not transmitted properly to the tissues surrounding the bladder. urethra. In this situation, pressure peaks greater than 100 cm of water cannot be compensated with the sphincter mechanisms, which cannot exceed 50 cm of water, resulting in the loss of urine. Being a mechanical problem, so far there are no drugs that cure it, and very rarely reduce it.

The treatment by surgery aims in various ways to fix the bladder to the bony or ligamentous structures of the neighborhood to prevent it from moving during efforts. There are multiple surgical techniques for the treatment of stress urinary incontinence. Currently, transvaginal techniques are mostly used, that is, through incisions in the vagina and laparoscopic, that is, through tubes that pierce the skin of the abdomen.

In general, they are not very aggressive techniques, with little risk for life, but with a failure rate that increases progressively over the years after the intervention. However, they require one to several days of hospital stay and are not exempt from complications such as: inability to urinate during the first weeks requiring probes, suprapubic pain that requires the administration of analgesics, painful urination and other more specific cases of each technique used (Valle Gerhold J, Murillo Pérez C,

Timón Garcia A, et al: Experience with endoscopic urethrocervicopexy: Long-term results. Urol Spanish Act.

1993; 17: 595-597. Korman IU, Sirls LT, Kirkemo AK: Success rate of modified Pereyra bladder neck suspension determined by outcomes analysis. J Urol 1994; 152: 1453-

1457). Nor have paraurethral injections proven useful in this type of incontinence, their use being reserved in the case of permanent incontinence due to intrinsic sphincter deficit. Even in the latter case, its usefulness is discussed by the high rate of failures that occur over the months and that often force new reinjections of an expensive and non-problem-free material (Buckley JF: Injectable teflon paste for female stress incontinence: Long-term followup and results. J Urol 1993b; 149: 418 ^a ).

There are also various methods that occlude the urethra from the outside, that is, from the vagina, but that have not become popular despite the fact that they have existed for years, as they are impractical for many women since they need to be replaced every time they go to urinate, they cannot be used during sexual intercourse, they produce a permanent foreign body sensation and do not guarantee complete dryness.

So far the highest success rates to avoid incontinence have been achieved with the use of different artificial sphincters. The most widespread is that marketed by the American Medical System (US Pat No: i, 222, 311), as AMS-800. The device, once placed, requires, both for the control of continence and for urination, the correct activation and deactivation for several times a day of the valves that are housed in the labia of the vulva. In addition, these devices have many components (inguinal fat reservoir balloon, drain valve, filling pump, periurethral cuff, tubes and connections that must be placed as a mechano during the surgical procedure) and frequently some break down, forcing repairs that involve new interventions Surgical Another drawback is the maintenance of unnecessary pressure on the urethra permanently, except when it is deactivated in urination.

There are patents (US Patent No: 4,994,020 6,319,191 5,893,826 5,562,598 5,520,606 5,518,504 5,163,897 5,078,676) of multiple variants of this artificial sphincter, based on various mechanical, magnetic or electronic systems, all based on the principle of permanent closure during rest and active opening during urination

Another prosthetic device used is the TVT (tension free transvaginal tape), it is the GYNECARE TVT (Pat n ° 6,641,524). It is a mesh tape of inert material that suspends the urethra as if it were a sling, leaving the free ends of the tape in the subcutaneous fat above the pubis. The same system has been used for decades for severe incontinence with the removal of a tape of aponeurosis as a graft of the patient. These sling systems produce a tensionless cerclage of the bladder neck, preventing its displacement during coughing. It involves keeping the urethra inside the abdominal cavity during pressure peaks so that the transmission of pressures to the bladder and urethra remains the same (Meschia M: Tension-Free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women Int Urogynecol J Pelvic Floor Dysfunct. 2001; 12 Suppl 2: S24-27. Soulie M: Repair of female urinary incontinence with prolene "TVT": preliminary results of a multicenter and prospective survey: Prog Urol. 2000 Sep; 10 (4): 622-8.). There are other tapes marketed for cerclage of the bladder neck (SPARC Sling System of American Medical Systems) of devices that claim the same, as well as techniques with biological grafts obtained from the same patients (abdominal straight muscle aponeurosis) or other sources (fascia lyophilized can).

Another type of sphincter is the so-called Karran prosthesis (US Patent 6,095,969 (2000)). It is a device with a serum bag that is deposited in the abdomen by laparoscopy and is joined by a rubber tube, interrupted by a valve, which joins it to a rectangular pad that is sutured on the abdominal face of the urethra to transmit to this the changes in abdominal pressure detected by the bag. There are no clinical data on its usefulness. Use the principle of pressure transmission with a bag-reservoir system, a tube controlled by a valve and a urethral pad similar to the artificial sphincter. Nor has its clinical utility been demonstrated, which is unlikely to deposit the pad in the only area of the urethra that is guaranteed direct pressure transmission even in patients with incontinence.

However, with the present invention, the drawbacks of the devices known so far are solved by means of a single-component medical prosthesis that guarantees that the transmission of abdominal pressures to the full diameter is maximum, since it produces the bladder neck cerclage, thus limiting the pathological mobility of the urethra and distributes abdominal pressures to all surrounding tissues. DESCRIPTION OF THE INVENTION Brief Description

An object of the present invention is a medical prosthesis for surgical implantation in humans, preferably in women, hereinafter prostheses of the invention, useful for the treatment of stress urinary incontinence, and which is constituted by a closed bag or balloon as a single piece filled with serum, without air inside, similar in shape and size to a pure and deformable as the serum is not under pressure. It is placed from a vaginal incision to be lodged in the tissue that surrounds the urethra as a loop, with the ends inside the preperitoneal abdominal cavity or Retzius space. Being a single piece with liquid inside, it has the property of distributing equally and instantaneously the variations of the hydrostatic pressure that occur at each point of the device.

Another object of the present invention is the use of the prosthesis of the present invention in the treatment of female stress incontinence. The advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time she wants to urinate, as is the case with existing prostheses. In addition, the prosthesis only presses the urethra for the duration of the increase in pressure in the abdomen, avoiding the discomfort generated by devices that permanently press the urethra. The prosthesis has a great simplicity and reliability in its manufacture and its implantation is possible with a single incision in the vagina and in 30 minutes, allowing hospital discharge in a few hours after it. Detailed description

The present invention is based on the fact that the inventors have observed that stress urinary incontinence can be avoided by means of a specially designed medical prosthesis and object of this patent, based on the fact that said prosthesis facilitates a maximum hydrostatic and instantaneous transmission of the Abdominal pressure changes to the urethra. In addition, this prosthesis is simple to manufacture and install, low cost and maintenance free. Increases in abdominal pressure during cough, laughter, etc. They directly affect the prosthesis, especially in the free areas inside the abdomen, but also in the anterior area of the urethra and bladder neck, distributing the pressure through the rest of the urethra to collapse preventing urine leakage.

Thus, an object of the present invention is a medical prosthesis for surgical implantation in humans, preferably in women, hereinafter prostheses of the invention, which allows a hydrostatic transmission to the sphincter of abdominal pressure changes, useful for the treatment of urinary stress incontinence, and that is constituted by a bag or balloon as a single piece characterized by:

- It is a closed bag or balloon as a single piece filled with serum, without air inside, similar in shape and size to a pure and deformable as the serum is not tensioned. Said bag has great malleability, such as a surgical glove, - it is constructed of a biocompatible material, derived from silicone, and because it incorporates, included in its own wall, three areas of reinforcement that increase the resistance of the bag:

- an area of "wall reinforcement", in the form of a rectangle, with a width similar to the diameter of the cylinder corresponding to each size of prosthesis and length of two thirds of the total length of the prosthesis (Figure 1, RP) and comprising the entire outer perimeter of the wall of the prosthesis that surrounds the urethra (Figure 1, AE: outer area) and that prevents distention to the outside during pressure peaks, and

- two areas of "suture reinforcements" (Figure 1, RS), rectangular in shape, with a width of 4 to 6 millimeters and length of 20 millimeters that are equidistant to half the length of the cylinder in the area opposite the wall reinforcement, (Figure 1, AI: interior area), which leave unimpaired centimeters of bag between them corresponding to the area of direct contact with the periurethral tissues of the interior area (Figure 1, AIPU: interior periurethral area).

Being a single piece with liquid inside, it has the property of distributing equally and instantaneously the variations of the hydrostatic pressure that occur at each point of the device. This property guarantees that when the hydrostatic pressure in the abdomen is increased, for example with coughing, this pressure has a proportional impact on the urethra, occluding it and thus preventing urine from leaking. The dimensions correspond, when the bag is full, to those of a cylinder with a diameter between 5 and 20 millimeters and a length between 8 and 30 centimeters. The variation of the dimensions allows the ideal application to each patient according to their size.

The areas of reinforcement, which increase the resistance, are constituted by appliques of fabric mesh included in the silicone wall itself. In this way, the portion of the bag that surrounds the urethra, once surgically implanted, has a very soft internal face that facilitates its deformity depending on its greater or lesser filling and another outer face of greater hardness by having added a layer of tissue mesh encompassed in the silicone so that it does not deform with pressure changes. When the prosthesis is folded, during the surgical implant process, the two suture reinforcements can be contacted through the midline, so that if they are joined with a suture point, the prosthesis will form a loop (Figure 2). The two ends that are beyond the reinforcements are called loop ends.

Once the prosthesis is implanted, it will surround the urethra in a loop, leaving the two ends of said loop free inside the abdominal cavity, at the level of the so-called Retzius space (Figure 2). The closure of the loop is achieved by placing one or several stitches, joining the inner portions of the bag in the place where two of the mesh sconces have been placed. The other mesh sconce comprises the entire outer perimeter of the part of the prosthesis that surrounds the urethra and is intended to prevent distention to the outside during pressure peaks, which will thus fall entirely inside the loop, that is, on the urethra (Figure 1, RP). In summary, the loop is not distensible in the outer diameter and if it is inside.

During pressure increases on the portion of the prosthesis located in the abdominal cavity, that is, on the free ends and on the anterior face of the urethra, it is distributed equally to the entire interior of the prosthesis, including the inner wall of the loop, which stretches tending to close the urethra.

As in other interventions of this type, the scar reaction that will involve the prosthesis in the weeks following its placement contributes to keeping the urethra and bladder neck inside the abdominal cavity, even during increases in pressure. This means that during rest, unlike devices that emulate an sphincter artificially, there is no effect of the prosthesis on the urethra, leaving the continence in the hands of the patient's striated sphincter. During urination, the bladder detrusor muscle is contracted to increase intravesical pressure without affecting abdominal pressure while relaxing the striated sphincter, without interference from the prosthesis and therefore without requiring intervention of any kind by The patient on the prosthesis. During increases in abdominal pressure, such as cough, the fixation exerted by the device is similar to classic interventions or TVT, but pressure transmission is added to the tissues surrounding the bladder neck and urethra throughout its circumference, even when over the years Change the patient's anatomy, the cause of most of the failures of conventional techniques.

Thus, another object of the present invention is the use of the prosthesis of the present invention in the treatment of female stress incontinence.

In summary, the prosthesis of the present invention has technical characteristics that, after a specific surgical intervention for implantation in the human body, allow an effective control of urinary incontinence of the effort or stress type in women, which on the other hand are the most. The advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time he wants to urinate, just as other existing prostheses occur. In addition, the prosthesis only presses the urethra for a very short time, avoiding the discomfort and complications generated by devices that permanently press the urethra. The prosthesis has a great simplicity and reliability in its manufacture, and its implantation is possible with a single incision in the vagina and in 30 minutes.

BRIEF DESCRIPTION OF THE CONTENT OF THE FIGURES

Figure 1: Prosthesis, extended general view, where its different areas and reinforcements are defined. AE, outside area. AI interior area. RP, wall reinforcement. RS, suture reinforcement. AIPU, interior periurethral area.

Figure 2: Prosthesis, general view in the form of a loop as it will be after its surgical implantation. AE, outside area.

AI interior area. RP, wall reinforcement. RS, suture reinforcement. AIPU, interior periurethral area. S, stitch.

Figure 3. - Prototype of artificial abdomen.

Figure 4. - Sphincter and silicone connection.

Figure 5. - Pigskin urethra.

Figure 6. - Abdominal pressure profiles measured in patients

Figure 7: Surgical view of the vagina, eyelets of the fascia on the sides of the urethra.

Figure 8: Surgical view of the vagina, a dissector that crosses from one eye to the other over the urethra. The dissector has entered the abdominal cavity on the anterior aspect of the urethra and after surrounding it manages to go outside again. This will be the path that will house the prosthesis.

Figure 9: Surgical view of the vagina, a dissector that crosses from one eye to the other over the urethra to catch one end of the prosthesis from which to pull so that it is placed around the urethra.

Figure 10: Surgical view of the prosthesis surrounding the urethra before closing the loop. Being a very malleable device it is possible to fix the points from the outside, with great ease, adjusting them to the anatomy of each patient to later introduce the ends inside the abdominal cavity through the open eyelets in the endopelvic fascia.

Figure 11: Surgical view of the prosthesis with the closure of the loop concluded. Figure 12: Surgical view of the vagina, definitive situation with the ends of the loop inside the abdomen. To introduce them, it is enough to push with the help of tweezers, gradually the ends of the device while rotating the portion of the prosthesis surrounding the urethra. Figure 13: Anatomical image where the definitive location of the prosthesis is recreated in relation to the bladder, pelvic bones and uterus.

EXAMPLES OF EMBODIMENT OF THE OBJECT OF THE INVENTION. Example 1.- Construction of the prosthesis and its test in an experimental model

An experimental model was designed and constructed comprising an artificial abdomen where to simulate the different pressures that take place in the abdomen (Figure 3) and study the prototypes of the prosthesis of the present invention. On the other hand, suitable software was developed for programming pressure profiles, to be used in the following tests, with characteristics similar to those that take place in patients.

Likewise, different devices were designed and constructed, for experimentation in said model, based on the principle of operation of the prosthesis of the present invention (see Figures 1 and 2), but with the necessary modifications to be able to be tested in the abdomen artificial previously mentioned. This original device, which mimics the prosthesis of the present invention, consists of three parts: the serum balloon, the sphincter and the silicone tube that connects them (Figure 4). In addition, in order to perform the experiments, an artificial urethra was made with pig skin, which simulates the human urethra (Figure 5). The artificial urethra was added to the artificial abdomen, the sphincter was placed around it and connected to the balloon, which It is housed inside the artificial abdomen, using a silicone tube. The connection tube was blocked with a clamp so that there was no pressure transmission and the sphincter did not close.

The purpose of the simulation complex described is to confirm that there is no delay in the transmission of pressures due to the materials used, so that the occlusion of the urethra is synchronous with the moment of incontinence, arriving in time to avoid it, as well as to establish the measures of the prosthesis that are suitable for said occlusion.

Initially, different pressure profiles were programmed in the artificial abdomen similar to those that cause urine loss patients and it was found that in our experimental model these profiles also caused fluid losses similar to those observed in patients. That is, the pressure increases that take place in the abdomen were measured when the patient coughs, sneezes or exerts some kind of effort (Figure 6) and said pressure profiles in the artificial abdomen were reproduced. Basically they consisted of pulse trains of between 100 and 150 mbar of pressure with a duration of 1 s and separated 5 s between them. Then when applying the pressure pulses to the artificial abdomen, with the clamp blocking the connection between the balloon and the sphincter, it was observed that coinciding with these pulses, losses of liquid were produced through the urethra.

Subsequently, the experiment was repeated, but now removing the clamp and thus allowing the transmission of pressures. When applying the pressure pulses now there were no losses because the sphincter closed while increasing the pressure in the bladder. That is to say, that the pressures were applied hydrostatically on the serum balloon, this one transmitted them through tube to the sphincter that closed on the urethra every time a pulse was applied. Thus, the same increase in pressure that causes the loss of urine is the one that closes the sphincter avoiding it. With this experiment it was demonstrated that the sensory device of latex, or of another material such as silicone, is perfectly valid at the experimental level and that it can be applied in humans.

Example 2.- Surgical implantation of the prosthesis of the present invention.

Before implantation, the prosthesis has an elongated shape as an easily deformable tube or bar.

This prosthesis consists of a bag or balloon as a single piece characterized by:

- it is a bag or balloon completely closed, elongated, like a surgeon's glove finger filled with physiological serum, said bag has great malleability as it is not completely filled with serum, without air inside, it is constructed of a material biocompatible, silicone derivative, and because it incorporates, included in its own wall, three areas of reinforcement that increase the resistance of the bag:

The prosthetic bag of the present invention, half full of liquid, does not contain air or other gaseous element, so that the filling volume thereof does not become complete to guarantee the deformity of the assembly and allows the movement of the serum of inside the bag according to the forces that act in each area of the prosthesis. In this way the bag is compressible but not distensible from a maximum. It should be noted that if the bag were completely filled it would not be easy to mold the prosthesis on the structures on which it rests. By way of example, it can be filled by hand, Squeeze a little to completely purge the air and then heat seal. If necessary, and as in the manufacture of other similar prostheses, a thicker wall area is left where the interior can be punctured to fill, empty or purge the air.

The dimensions correspond, when the bag is full, to those of a cylinder with a diameter between 5 and 20 millimeters and a length between 8 and 30 centimeters. The variation of the dimensions allows the ideal application to each patient according to their size.

The areas of reinforcement, which increase the resistance, are constituted by appliques of fabric mesh included in the silicone wall itself. The mesh is part of the material since it is injected into the mold during its manufacture. On an industrial level it is simple (for example in the manufacture of reinforced hoses) and usually used in other devices such as testicular prostheses or urethral probes.

The prosthesis of the present invention is placed in a patient making an inverted "U" incision in the anterior wall of the vagina, below the urethral meatus, which exposes the urethra and on its sides some membranes called endopelvic fascia. By opening a buttonhole of several millimeters on each side of the urethra, the fatty tissue inside the abdomen is accessed (Figure 7). With a curved instrument it is possible to enter through one buttonhole and exit through the other, thus surrounding the urethra in its intra-abdominal portion and surrounding tissues without damaging them.

(Figure 8). Catching one end of the prosthesis with the mentioned instrument and pulling it is achieved that said prosthesis surrounds the entire urethra, including the surrounding fat and venous plexus from the labia minora and the clitoris, entering through one eyelet and exiting through the other (Figures 9 and 10). The prosthesis loop is closed by suturing the suture reinforcements together, so that it fits without pressing the urethra (Figure 11). By means of maneuvers of rotation of the loop and thrust of the ends it is achieved that these enter through one of the eyelets of the endopelvic fascia, being housed inside the abdomen (Figure 12). This is facilitated by the partial filling of the bag that allows optimum malleability. Finally, the vaginal mucosa is sutured (Figure 13).

In this way, the portion of the bag surrounding the urethra, once surgically implanted and due to the technical characteristics of the prosthesis itself of the present invention, has a very soft internal face that facilitates its deformity depending on its greater or lesser filling. of serum and another external face of greater hardness when having added a layer of mesh of tissue encompassed in the silicone so that it does not deform during the pressure peaks, and that in this way they will fall entirely inside the loop, that is, on the urethra In summary, the loop is not distensible in the outer diameter and if it is inside. When the prosthesis is folded, during the surgical implant process, the two suture reinforcements can be contacted through the midline, so that if they are joined with a suture point, the prosthesis will form a loop (Figure 2). Once the prosthesis is implanted, it will surround the urethra and surrounding tissues in a loop, leaving the two ends of said loop free inside the abdominal cavity, at the level of the so-called Retzius space (Figure 2). In this way, the prosthesis is placed inside the patient without direct access to it. It is not necessary to activate anything to make it work, since its effect is achieved entirely passively. Thus, during a baseline rest situation nothing happens when the pressures are balanced. In this situation, unlike devices that resemble an artificially shaped sphincter, there is no effect of the prosthesis on the urethra, leaving the continence in the hands of the striated sphincter, which has not been touched during the insertion of the prosthesis and works correctly, as it will have been verified before indicating the intervention.

However, during abdominal pressure increases, such as a coughing stroke, over the portion of the prosthesis located in the abdominal cavity the pressure is distributed equally throughout the interior of the prosthesis, through hydrostatic transmission through the serum of its interior, that is, on the free ends and on the entire bag that surrounds the urethra, including the inner wall of the loop, which stretches tending to close the urethra. When the hydrostatic pressure of the abdomen increases, a small amount of physiological serum will circulate in the direction of the vagina to balance the pressures throughout the system and when this ceases, it will happen the other way around. The only thing that will circulate will be a very small amount of liquid, and the pressure will always be the same throughout the system.

In addition, and as in other interventions of this type, the scar reaction that will involve the prosthesis helps keep the urethra and bladder neck inside the abdominal cavity, even during increases in pressure to the hinder the sliding of the urethra to the outside of the abdomen, which can adequately receive such increases in pressure as well as the bladder, so that the urethra can collapse thus contributing to a more effective continence. The fixation that this prosthesis exerts is similar to the classic surgical interventions or to the TVT, but the facilitation for the transmission of pressure in the entire circumference of the urethra is added, even when the anatomy of the patient changes over the years, cause of most of the failures of conventional techniques.

During urination, the bladder detrusor muscle contracts while the muscular sphincter relaxes, without interference from the prosthesis.

In summary, the advantage of the prosthesis of the invention is that it works automatically, without the patient having to manipulate the device every time he wants to urinate, as is the case with existing prostheses. In addition, the prosthesis only presses the urethra for a very short time, avoiding the discomfort generated by devices that permanently press the urethra. The prosthesis presents a great simplicity and reliability is its manufacture and its implantation is possible with a single incision in the vagina and in 30 minutes.

Claims

1.- Prosthesis for surgical implantation in humans, preferably in women, which allows a hydrostatic transmission to the urethral sphincter of abdominal pressure changes characterized in that it is a bag or balloon as a single piece completely closed in an elongated tubular shape, such as a thin, half-full sheet of liquid, preferably of physiological serum and because it incorporates, included in its own wall, reinforcement areas that increase the resistance of the bag.

2. Prosthesis according to claim 1 characterized in that the reinforcement areas are constituted by: a) a "wall reinforcement" area, in the form of a rectangle, with a width similar to the diameter of the cylinder corresponding to each prosthesis size and length two thirds of the total length of the prosthesis (Figure 1, RP) and comprising the entire outer perimeter of the wall of the prosthesis that surrounds the urethra (Figure 1, AE: outer area) and that prevents distention to the outside during the pressure peaks, and b) two areas of "suture reinforcements" (Figure 1, RS), rectangular in shape, with a width of 4 to 6 millimeters and length of 20 millimeters that are equidistant at half the length of the cylinder in the area opposite to the wall reinforcement, (Figure 1, AI: interior area), which leave unimpaced centimeters of bag between them corresponding to the area of direct contact with the periurethral tissues of the interior area (Figure 1,

AIPU: interior periurethral area).

3. Prosthesis according to claims 1 and 2 characterized in that the bag or balloon has the thickness of a paper and a great malleability.

4. Prosthesis according to claims 1 and 3 characterized in that it is constructed of a biocompatible material.

5. Prosthesis according to claim 4 characterized in that the biocompatible material is silicone or latex.

6. Prosthesis according to claims 1 to 5, characterized in that its dimensions correspond, when the bag is full, to those of a cylinder with a diameter between 5 and 20 millimeters and a length between 8 and 30 centimeters, depending on the specific application of every one of them .

7. Use of the prosthesis according to claims 1 and 6 in the treatment of female stress incontinence.