2012 Afex® Clinical Evaluation – Budapest

Expert’s Report on the Test of Afex® Incontinence Briefs [Male Incontinence System]

Drafted: At the Urology Clinic of the University of Szeged, after preliminary licensing,

1 July to 31 August 2012

Test Leader: Prof. Dr László PAJOR, Professor and Head of Department

 

1.    Definition of Incontinence

Incontinence is the involuntary loss of urine via the urethra, which hinders the individual’s social integration. It is a symptom that may emerge as a result of a number of urological, internal, neurological and gynaecological diseases. The symptom entails a sense of shame, the patient often keeps it secret even from his or her closest family members. This results from the fact that leaked urine produces a disagreeable moisture content and odour in one’s clothing. This significantly limits the individual’s social roles, entertainment and job opportunities alike. Nighttime incontinence deteriorates the quality of rest, which leads to the lack of sleep.

The types of incontinence differ due to the underlying disease and the extent of incontinence. Stress incontinence (the term is misleading) mostly occurs in women. It can be well treated by operation and exercise. Compelling incontinence occurs when the urge to urinate arises imperatively, the patient cannot reach the toilet, thus urine leakage appears before it. This occurs more often in women, but also occurs in men, and can be well influenced by medication.

2.     Therapeutic Aid Needs

If curable forms of the incontinence are involved, a therapeutic aid is only needed temporarily, at most. It frequently occurs, however, that the incontinence cannot be influenced or can only be eliminated by a high-risk intervention. A good solution is the use of therapeutic aids, which allows the patient to get reintegrated into society. In Hungary, a generally accepted and available method applied among therapeutic aids is pads of various sizes, designed to be permeable to air; the pad can absorb an amount of the liquid several times its own weight. It hinders leakage, allowing the patient to move around to a limited extent and to regain his or her previous level of activity and to work.

3.     Incontinence in Men

It emerges as a result of a previous urology operation almost without exception. Its primary cause is radical prostatectomia performed due to prostate cancer. The operation is good, it can definitively cure the patient’s prostate cancer. Its fault is that according to international statistics, it causes incontinence to varying extents, 10% to 20%. The reason for the loss of urine is that the operation is performed very close to the detrusor urinae muscle, thus it may damage its nervous control, and even its muscle fibres. New operating techniques have reduced the risk of development of incontinence, but it has still remained in a certain percentage of cases. The treatment of incontinence in men with therapeutic aids differs from that in women. The difference has anatomical reasons: The urethra in men is longer, and the external genitalia have a different shape. Nonetheless, proven incontinence pads and diapers are also available commercially in Hungary. For slight incontinence, it is pocket shaped, thus it can be pulled over the penis. For severe incontinence, the edge of the diapers is designed in such a way that even after the moisture absorbing capacity is exceeded, it will not allow the urine to leak. However, diapers hinder the patient in his or her movement, they are more visible when used, which bothers men. It is especially to be ashamed of if a man has to replace a pad by interrupting his activity during the day, while the same is better accepted in the case of women due to their menstruation. Countless experiments have been conducted to solve the problem, one of them being the use of a condom catheter. It is a rubber bell, which the patient pulls over his penis. There is an outlet tube at it tip, which leads to a urine drainage bag through an extension. The application is impaired by the fact that the skin of the penis becomes soaked due to the urine and the condom often slips off, which suddenly makes the patient wet. Therefore, there is no solution to provide [appropriate] therapeutic aids to the inoperable and definitive incontinence in men. In Hungary, the US-based company Arcus Medical LLC has carried out the development of the special incontinence briefs distributed exclusively by Euromedic Trading Kft. (Ltd.).

4.    Structure of Incontinence Briefs [Afex® Male Incontinence System]

The device consists of flexible textile briefs that wash well and are highly permeable to air, with a separate plastic pouch for the penis in its front middle part, the lowest point of which an outlet tube and a plastic bag can be connected to. The tube continues directly up to the urine bag, but it can also be mounted on a stand with an add-on unit, which allows even more freedom of movement. Thus, in a standing position, the urine is discharged into a funnel-shaped plastic collector and drains into the urine bag. It cannot flow in a reverse direction from the bag, as this is prevented by a valve. The plastic pouch of the penis washes well, contains no latex, is cleanable and has a rounded rim, thus it does not irritate the skin. The outlet starts from the lowermost point of the penis pouch, thus no backflow is possible. Two forms of the penis pouch can be ordered: One is shorter, while the other is provided with a supplementary rim increasing its length. The shorter version is recommended in case the patient is in a sitting position for long periods, which is particularly comfortable for patients confined to a wheelchair. If the patient typically sleeps on his or her back, the nighttime penis pouch and the outlet tube can be used without alteration; if, however, the patients changes his or her position during sleep, the penis pouch can be provided with a supplementary tube, which offers better drainage. The incontinence briefs may not be used in a prolonged prone position. The extension of the outlet tube may also be useful if the collection bag cannot be replaced at will, because this way it can also be connected to a larger bag placed at the patient’s feet. Typical examples for this are long drives or flights. The urine bag or bag placed at the patient’s feet is easy to empty and can be reconnected to the device during the day. The external appearance of the briefs does not differ from that of common underpants, it has no pad inserted, thus the therapeutic aid cannot be noticed at normal sight.

Naturally, it is clearly visible after taking off one’s clothes. Therefore, drainage of the urine is ensured by gravity, and since the outlet is at the lowermost point of the penis pouch, it works under any circumstances. Consequently, the device can be used with no dripping and odours both during the day and at night. The urine does not leak in a vertical position or even while playing or going sports, but drains to the urine bag.

5.    Target Group Wearing the Incontinence Briefs [Afex® Male Incontinence System]

For the reasons set out above, the device can be recommended mostly for men who have an active life during the day, work or play or go sports. It is also recommended for physically handicapped incontinent men (confined to a wheelchair) or incontinent men with a sedentary job, who still use a catheter for urine drainage under compulsion. Exceptions to these are, naturally, patients suffering from high pressure or overflow incontinence or incontinent with a significant amount of residuum. Its handling is simple, ensures a complete lack of odours and dripping, remains hidden under clothes, and is not unaesthetic. It is a special advantage that the urine bag can be easily discharged in any toilet, and the frequency of drainage corresponds to that of normal urine voiding. From a technical point of view, the device is of a very high standard, and its design, anti-allergenic property, ventilation and washability are first class. However, attention must be drawn to the fact that its nighttime application is perfect with accessory objects.

At the Urology Clinic of Szeged, 15 patients have been provided with Afex® briefs; seven patients received an A100 Afex® basic set, and eight patients received an A100 basic set plus an add-on unit (A400L, A800, A700A, A700S, A400X for sleeping on their back and using them under sedentary conditions) for trying. The patients were asked for their opinion after wearing the device for at least three months.

The questions were as follows:

5/1. How has your quality of life changed since wearing the urine collecting briefs? Please place this on a scale between –10 and +10.

Average: +7

5/2. Have the briefs improved or hindered your physical activity? Please indicate this on a scale between –10 and +10.

Average: +6

5/3. When is the advantage of using the briefs more pronounced: at night or during the day? If at night, enter 1, and if during the day, enter 2.

Average: 2

5/4. Is it easy or difficult to use and clean the briefs? Indicate this on a scale between –10 and +10.

Average: +10

5/5. Please state your own experience and opinion about the briefs.

In general, the patients reported favourable experience, but the material caused them to sweat in the extreme heat of this summer. During summer, it limited the use of briefs by the patients. There was also a note whereby the size of the funnel placed on the penis may be too large if the size of the penis of the patient does not exceed the normal level.

On the whole, the patients were happy with the new device, and this changed the inconvenience represented by urine incontinence so far.

6.    Advantages of Incontinence Briefs [Afex® Male Incontinence System]

The briefs [Afex® Male Incontinence System]

– collect urine with no dripping and odours;

–  can be worn aesthetically and cannot be recognised when worn under normal clothes;

–  do not hinder the patient’s active everyday life, improve social integration and relieve the psychic burden of incontinence;

–  improve the quality of life;

–  are easy to handle and clean;

–  their preceding clinical documentation is very good;

–  their clinical suitability is excellent;

–  the user manual is competent and easy to understand;

–  are much more comfortable than conventional pads and provide a better quality of life;

–  are environmentally sound, because no large amounts of polluting diapers are produced.

7.    Disadvantage of Incontinence Briefs [Afex® Male Incontinence System]:

–   The briefs may not be used in the case of a micropenis.

 

Szeged, 10 September 2012

<Illegible signature>

Prof. Dr László PAJOR

Professor and Head of Department

Clinic Director

 

Stamp of the Urology Clinic of the

Szent-Györgyi Albert Clinical Centre,

University of Szeged