WO1998047557A1

WO1998047557A1 - Method for the diagnosis, treatment and prophylaxis of premature ejaculation and catheter for the diagnosis, treatment and prophylaxis of premature ejaculation

Info

Publication number: WO1998047557A1
Application number: PCT/IT1998/000088
Authority: WO
Inventors: Giuseppe La Pera
Original assignee: Pera Giuseppe
Priority date: 1997-04-23
Filing date: 1998-04-15
Publication date: 1998-10-29
Also published as: AU7078298A; ITRM970235A0; IT1291890B1; ITRM970235A1

Abstract

The present invention relates to a method for the diagnosis, treatment and prophylaxis of premature ejaculation comprising induction of dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter and a catheter (1) for the diagnosis, treatment and prophylaxis of premature ejaculation comprising a tube (2) fitted with at least one passage for fluids (5), a passage for inflation (6), and inflatable means (3), fitted outside said tube (2), suitably positioned to interact with the bladder neck and/or the preprostatic sphincter, said means being inflatable through said inflation passage (6) and being frusto-conical in the shape with its wider end towards the bladder neck and the narrower end towards the urethral meatus.

Description

METHOD FOR THE DIAGNOSIS, TREATMENT AND

PROPHYLAXIS OF PREMATURE EJACULATION AND

CATHETER FOR THE DIAGNOSIS, TREATMENT AND

PROPHYLAXIS OF PREMATURE EJACULATION.

The invention relates to a method for the diagnosis, treatment and prophylaxis of premature ejaculation and to a catheter for the diagnosis, treatment and prophylaxis of premature ejaculation. The catheter in particular constitutes a determinant feature in making use of this method and in resolving the problem of premature ejaculation.

The various means of treating this condition reflect uncertainties regarding the physiology of ejaculation, the exact sequence of the action of the anatomical parts involved and the chemical mediators released. These uncertainties also emerge in the numerous and undemonstrated pathogenic hypotheses.

Psychological treatments are among those frequently used at present. Despite their wide-spread use however, controlled trials have never demonstrated that they are really effective nor have the pathogenic hypotheses supporting the rationale of the theory of the therapy ever been demonstrated.

This kind of therapy is often accompanied by treatment with anaesthetic creams, antidepressive cyclic drugs, behaviour and relax techniques and more recently by the rehabilitation of the pelvic floor.

Results achieved with most of these and other therapies have not been satisfactory and so far no controlled studies with adequate follow-up exist.

The invention presented here, designed to solve this problem, is based on the hypothesis that one of the main pathogenic mechanisms of premature ejaculation lies within the prosthatic urethra, still not thoroughly understood.

The sperm accumulation chamber is comprised of the prosthatic urethra, the bladder neck which closes above the accumulation chamber and the outer urethra sphincter which closes it at the other end.

During the so-called accumulation phase the sperm gathers in this chamber causing an increase in pressure inside the urethra.

According to the hypothesis on which this invention is based, the ejaculatory reflex is induced when a certain amount of pressure is built up within this chamber. In some cases, the ejaculatory reflex is induced before the patient wishes with only a small amount of seminal fluid either because the urethra wall is not very elastic or because the threshold for reaction to increased pressure is low, or because the patient is unable to make the ejaculation inhibition mechanism perform properly.

Underlying this invention is an intuition of the Applicant that the relaxation of the pelvic floor - which inhibits the ejaculatory reflex in normal males - causes the bladder neck and/or the preprosthatic sphincter to open and a certain quantity of sperm to leak from the intraprostatic accumulation chamber resulting in a drop in pressure in the prosthatic urethra. Consequently the pressure built up within the prosthatic urethra is probably not enough to trigger the ejaculatory reflex.

The new theory, never described before, lies in the fact that this mechanism does not properly works in patients with premature ejaculation.

In premature ejaculators, the so-called accumulation chamber has no vent for releasing the pressure generated as the sperm accumulates because the bladder neck and/or the preprosthatic sphincter does not open at the right time. Therefore the pressure required to trigger off the ejaculatory reflex is reached very quickly.

The conclusions of the experiments carried out are based on the observation of 26 patients during a bladder and prostate ecography.

Ten of them said they were able to control the ejaculatory reflex and to delay ejaculation as long as they wished. The other 15 suffered from premature ejaculation according Hellen S. Kaplan's definition.

During the ecographic examination, all the patients were asked to perform the relaxation of the pelvic floor so as to mime the ejaculatory reflex inhibition movement.

While normal males performed the movement correctly with the consequent opening of the bladder neck, in the majority of cases of patients with premature ejaculation the bladder neck failed to open.

There are two explanations for this failure to open. In some patients the so-called "command inversion" phenomenon occurred. That is, in their attempt to relax the pelvic floor, some patients relaxed the abdominal and thigh muscles instead, without performing the pelvic floor relaxation movement correctly. In about half of the cases, in spite of a correctly performed movement, the bladder neck did not open for reasons intrinsic to the bladder neck and/or the preprosthatic sphincter itself.

This invention is therefore based on the discovery that during sexual intercourse in males with premature ejaculation the opening of the bladder neck and/or the preprosthatic sphincter which acts as a vent fails to occur.

In premature ejaculators, for the most part, the bladder neck and/or the preprosthatic sphincter fails to open either because the person is unable to perform correctly the pelvic floor relaxation movement which opens the bladder neck and/or the preprosthatic sphincter or because the bladder neck and/or the preprosthatic sphincter cannot open. This inability can be caused either by a spastic or sclerotic condition or by insufficient neuromodulation, or by the insufficient activation or functioning of the alfalytic system.

This pathogenic hypothesis is supported by two clinical observations, one of which is an easily noticeable through empirical observation.

The amount of seminal fluid produced during the second sexual intercourse is highly less than the amount produced during the first one.

In view of the above, it seems to be obvious to reach the conclusion that the reflex is better controlled since the reduced production of seminal fluid determines a slower increase of the pressure within the urethra. The end result is a delayed ejaculatory reflex. The second correlation can be noted in patients who have undergone a prosthatic adenomectomy. In fact, in these cases surgery involves opening the bladder neck. After surgery the patient often suffers from retrospermia due to the permanent opening of the bladder neck which no longer closes off the prosthatic urethra. As sperm accumulates it flows from the prosthatic urethra back into the bladder.

When the orgasm occurs, although the patient experiences pleasure, he does not release seminal fluid because it has flowed back into the bladder and is eliminated in the next micturition. Moreover, in patients with premature ejaculation who subsequently undergo surgery for a prosthatic adenoma, a considerable improvement in the ejaculation reflex has been noted. The invention presented here as a solution to this condition, springs from this observation. It consists of opening the bladder neck and/or the preprosthatic sphincter and creating a new exit for the sperm during the accumulation phase, so as to keep pressure low within the urethra and delay the ejaculatory reflex.

In this way, there is a lengthening of the latency time before ejaculation during sexual intercourse. The dilation, opening or relaxation of the bladder neck and/or the preprosthatic sphincter acts both as a vent for the release of the seminal fluid which accumulates and as a mechanism altering the receptors which are located in this region and which trigger ejaculation.

A number of solutions using inflatable catheters are available for the treatment of the prostate. For the most part, they consist of a balloon elliptical in shape, positioned inside the urethra and inflatable from outside.

Some examples are described in European patent applications nos. 0 442 480, 0 421 0331 , 0 341 988, 0 345 051 and in international patent applications nos. WO 92/181944, WO 92/04934, W0 95/03848 and WO 96/27406. None of these publications describe solutions suitable for solving the problem which is at the basis of this invention. All of them propose more or less complex solutions involving a catheter equipped with an inflatable balloon which interacts with the prosthatic urethra in an attempt to resolve the prostate problem. Instead the invention described here aims at providing a real solution to the problem to premature ejaculation.

The action of the catheter presented here, is not to squeeze the prosthatic urethra as the other balloon-shaped prosthatic dilators do, but rather, thanks to its shape, to create an effect similar to that which occurs after the surgical operation described above.

Furthermore, the solution obtained through this invention ensures the reversibility of the phenomenon, allowing the patient to procreate if he wishes.

The specific aim of this invention is to permit the diagnosis, treatment and prophylaxis of premature ejaculation by inducing a dilation, opening or relaxation of the bladder neck and/or the preprosthatic sphincter. Dilation, opening or relaxation may be effected through mechanical means, hyperthermia, microwaves or other kind of energy, or by pharmacological therapy. In the case of pharmacological therapy, pharmaceuticals antagonist of the alpha-adrenergic receptors, particularly anti alpha 1 a, b, c, d, alpha 2, and their salts, are preferable. It is specific object of the present invention a catheter for the diagnosis, treatment and prophylaxis of premature ejaculation, comprising an inflation passage and an inflatable means on the outside of the tube, suitably positioned to interact with the bladder neck and/or the preprosthatic sphincter which can be inflated through the inflation passage which constitutes the invention. The inflatable means is frustro- conical in shape with the wider end towards the bladder neck and the narrower end towards the urethral meatus. There is at least one passage for fluids.

Near the tip of the catheter which is introduced into the bladder, there is a second inflatable means, fitted with a second inflation passage, which serves to anchor the tube in the bladder.

Furthermore the first frustro-conical-shaped inflatable means, with the larger base towards the bladder, may be 2 -7 cm in length and 3

-5 cm in diameter at the widest part and about 0.5 cm at the narrowest. The first inflatable means is inflated for 10 -20 minutes to attain a pressure of 2 - 6 atmospheres.

The second inflatable means positioned at about 2 cm. from the tip of the catheter can inflate to a volume of about 5 - 30 cc;

Furthermore on the end of the anchoring means faced toward said frustro-conical shaped inflatable means, there is a marker.

Furthermore all the components of the catheter can be echo and/or radio reflecting.

The invention will now be described for illustrative but not limitative purposes, in its preferred embodiments. Reference will be made to the figures in the attached drawings, wherein: figure 1 is a schematic view of one embodiment of the catheter; figure 2 is an enlarged view of the catheter shown in figure 1 ; figure 3 shows the outer end of the catheter shown in Figure ; and figure 4 is a cross section view taken along line IV-IV of figure

3; The figures show a catheter 1 with a plastic tube 2, a first inflatable balloon 3 and a second inflatable balloon 4 for anchoring the catheter.

In figures 3 and 4 in particular, it can be noted that the tube 2 has three different inlets 5, 6 and 7, respectively for the guide wire or for the passage of water or urine, for the inflating first balloon 3 and for the second inflating balloon 4. The second balloon 4 is positioned about 0.5 cm from the first 3 and can be inflated to a volume of 5 to 50 cα, as is normal for catheters. It serves to hold the catheter 1 in the bladder during treatment and to ensure that the action of the first balloon 3 occurs in the neck. The anchoring element is a not new feature in bladder catheters.

The first balloon 3 is positioned on the tube 2 of the catheter 1 just below the second balloon 4. The first balloon 3 too is inflated from the outside through the tube 6, using water, air or other means. As figures 1 and 2 show, the first balloon 3 is frustro-conical in shape which makes it particularly suitable for acting on the bladder neck. The wider part of the cone faces the inner tip of the catheter 1 and the narrower, the point of insertion of catheter 1.

The length varies according to the length of the prostate urethra. It is usually 4-6 cm. long but can be shorter or longer. The length is measured by echography through a transrectal probe.

The diameter of the larger base of the first balloon 3 can vary from 3 - 5 cm. The width of the narrow end can also vary but the first balloon 3 usually protrudes from catheter 1 only 0.5 cm. The first balloon 3 is connected to a pump or similar device by which it can be inflated to a pressure of about 2 - 6 atmospheres so as to dilate the bladder neck (and if necessary, also the prosthatic urethra and/or the preprosthatic sphincter). In this way the bladder neck remains open allowing the sperm to flow back into the bladder in the sperm accumulation stage during sexual activity.

On the outer edge of the narrow end of the frustro-conical balloon 3 the catheter has a marker bulge 8 which is identifiable through rectal digital or echographical examination.

During use the catheter 1 is inserted into the urethra after the patient has had a local or loco regional anaesthesia, neuroleptoanalgesia or other kind of anaesthetic. The anchor balloon 4 is inflated and the catheter 1 is put in traction. Then, using the outer inflating pump (not shown) the frustro- conical balloon 3 is inflated to a pressure of about 4-6 atmospheres although this pressure may be lower or higher. Dilation, opening or relaxation time may vary; it generally takes

10-20 minutes to dilate the bladder neck and possibly also the prosthatic urethra and/or the preprosthatic sphincter.

The first balloon 3 makes it possible to achieve greater dilation, opening or relaxation at the neck of the bladder and/or the preprosthatic sphincter without risk of damaging the sphincter of the urethra causing incontinence.

The dilation, opening or relaxation of the first balloon 3 makes it possible to position the same well above the sphincter.

By dilating the bladder neck and/or the preprosthatic sphincter (and partially the prosthatic urethra) it is possible for the sperm to flow back into the bladder as it accumulates in the prosthatic urethra during sexual intercourse. This means that there will be a lengthening of ejaculation time and even better control of the ejaculatory reflex.

An example of how this method and the catheter work will be described below.

A multi-channel catheter is introduced through the urethra and the prosthatic urethra is measured. Measurement can be made by echographic or radiological means or by using a graduated measuring catheter at the distal end of which there is an anchoring device such as a balloon.

After the catheter has been inserted into the bladder, the inflatable means is inflated and the catheter is slightly withdrawn until it engages the inflated means to the bladder neck. The distance between the inflatable means and the external sphincter of the urethra is measured. A graduated catheter can also be inserted through one of the channels of an optical fibre instrument.

Once the appropriate size of the inflatable means has been decided the catheter fitted with an anchoring device is inserted through the urethra and it is inflated. The catheter is then withdrawn slightly until the anchoring means engages the walls of the bladder neck and then the inflatable means is inflated. Dilation, opening or relaxation time varies according to the different cases; it may be rapid, progressive or slow - it may even last a few weeks in which case the means of inflation may comprise expanders.

Once dilation, opening or relaxation is completed the inflatable is deflated and the catheter removed.

The catheter may even be fitted with a positioning device, consisting of a third inflatable means located closer to the dilating device or may consist of a bulge in the catheter, detectable by digital rectal examination during the positioning procedure. As has already been mentioned, this method also comprises pharmacological treatment.

In this regard, the outcome of some tests reported below shows that better ejaculation control is achieved by opening, relaxing or dilating the neck and/or the preprosthatic sphincter. Patients were treated with Tamsulosin® used in the treatment of prosthatic adenoma. This drug has a specific antagonist action on a1 adrenergic receptors in the bladder neck.

The use of this drug determines an opening in the bladder neck and a reduction in the obstruction of the urinary flow caused by the prostate. A drug which causes such an effect in the context of this invention provides an outlet for the semen with a lowering of the pressure within the prostate urethra during sexual intercourse. Consequently the ejaculatory reflex may be delayed.

23 patients between the ages of 24 and 56 (average age of 38), with premature ejaculation as defined by Hellen Kaplan were examined. The time from penetration to the ejaculation reflex was less than one minute or occurred after the first 8 - 10 thrusts.

14 patients had already been treated unsuccessfully with "Stop and Start" therapy and with anaesthetic creams or with psychological therapy. None of the patients examined had erectile deficiencies or prostate inflammation. The symptom had been present for at least two years. Each patient took one tablet per day of the above-mentioned drug. After about 1 month of treatment, the following results were obtained.

12 of the patients had significanty increased ejaculation time, - from a minimum of more than 2 minutes to even 10 -15 minutes. 8 patients showed no clinically significant increase. Suspension of the drug brought about a return to the previous situation. When treatment was started up again, there was a recovery of the beneficial effects. 2 of the patients who had reacted positively to treatment noted a retrospermia effect. In three cases it was necessary to interrupt treatment as patients experienced excessively low blood pressure. Although the experiments were carried out without the so-called

"double blind", the disappearance of the effects following the suspension of the drug and the benefits regained when the drug was used again, show indirectly that the drug is effective in treating premature ejaculation. These tests show that the opening of the bladder neck is the key to the control of premature ejaculation.

The present invention has been described for illustrative but not limitative purposes, in its preferred embodiments. It is understood however, that variations and/or changes may be introduced by experts in the field without affecting the protection rights claimed in the following list.

Claims

1. Method for the diagnosis, treatment and prophylaxis of premature ejaculation characterised by induction of dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter.

2. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 1 , characterised in that said dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter is effected by mechanical means.

3. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 1 , characterised in that said dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter is effected by hyperthermia.

4. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 1 characterised in that said dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter is effected by microwaves or other kinds of energy.

5. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 1 , characterised in that said dilation, opening or relaxation of the bladder neck and/or the preprostatic sphincter is effected by pharmacological therapy.

6. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 5, characterised in that said pharmacological therapy employs pharmaceuticals antagonist of alpha- adrenergic receptors, in particular anti-alpha 1 , anti-alpha 2, anti-alpha 1a, anti-alpha 1b, anti-alpha 1c and anti-alpha 1d, and their salts.

7. Catheter for the diagnosis, treatment and prophylaxis of premature ejaculation, characterised in that it comprises a tube having at least a passage for fluids, a passage for inflation and an inflatable means located on the outside on the tube in a position suitable for interaction with the bladder neck, said means being inflatable through said inflation passage and having the wider end towards the bladder neck and the narrower end towards the outer end of the catheter.

8. Catheter according to claim 7, characterised in that it also comprises at least one passage for fluids.

9. Catheter according to one of the preceding claims 7 - 8, characterised in that it comprises second inflatable anchoring means on the said tube, near the end where the catheter is introduced into the bladder, fitted with a second inflating passage.

10. Catheter according to one of the preceding claims 7 - 9 characterised in that it comprises said first inflatable means the shape of which is substantially frustro-conical with the wider end towards the bladder neck and the narrower end towards the urethral meatus.

11. Catheter according to claim 10, characterised in that said inflatable means, substantially frustro- conical in shape, is about 2 - 7 cm. in length, and 3 - 5 centimetres in diameter at the wider end and about 0.5 centimetres at the narrower end.

12. Catheter according to one of the preceding claims 7-11 , characterised in that said first inflatable means is inflated for a period of 10-20 minutes, to a pressure of about 2-6 atmospheres.

13. Catheter according to one of the preceding claims 7-12, characterised in that the second inflatable means serving as an anchor is located at about 0.5 cm. from the first frustro-conical-shaped inflatable means and can be inflated to a volume of about 5 - 50 cc.

14. Catheter according to one of the preceding claims 7-13, characterised in that, on the end of the anchoring means faced toward said frustro-conical shaped inflatable means, there is a marker.

15. Catheter according to one of the preceding claims 7 -14 characterised in that all parts of the catheter are echo- and radio- reflecting.

16. Catheter according to one of the preceding claims 7-15, characterised in that it is fitted with positioning means made up of a third inflatable means located nearer the dilating means, or a bulge in the catheter allowing it to be identified by digital rectal examination during the insertion procedure.

17. Method for the diagnosis, treatment and prophylaxis of premature ejaculation according to claim 1 or 2, using a catheter according to one of the claims 7-16, characterised in that it comprises the following steps:

- insertion through the urethra of a multi-channel catheter and the measuring of the prosthatic urethra; - after insertion of the catheter in the bladder, inflation of the inflatable anchoring means and slight withdrawal of the catheter until the inflated anchoring means engages the bladder neck, followed by the measuring of the distance between the inflatable means and the external sphincter of the urethra;

- after having chosen the appropriate size for the dilating means, insertion through the urethra of the catheter fitted with an inflatable anchoring means, and inflation of the inflatable means.

- the slight withdrawal of the catheter until the inflated anchoring means engages the walls of the bladder neck and inflation of the dilating means;

- after completion of dilation, opening or relaxation, deflation of the inflatable means and the removal of the catheter.

18. Method according to claim 17, characterised in that measuring is performed using an echograph or radiological means or using a graduated measurement catheter at the distal end of which there is an anchoring device such as, for example, an inflatable means.

19. Method according to claim 18 characterised in that said graduated measurement catheter is inserted through one of the channels in an optical fibre instrument.

20. Method according to one of claims 17 - 19, characterised in that dilation, opening or relaxation time varies from case to case and may occur rapidly, progressively or slowly, and may even require a few weeks; in such cases, the dilating means is comprised of expanders.

21. Method according to each of claims 1-6 and 17 -20 and catheter according to the aforementioned claims 7 - 15 substantially as illustrated and described.