Indications

The Dilagent is indicated for the lower ano-­‐rectal diseases in which there is a hypertone of the internal sphincter as in the case of an anal fissure, haemorrhoids, anal pain and painful spasms after surgery in the ano-­‐rectal tract. It could also be used in the postoperative stenosis of the anus or anal canal.

Directions for use

Before using the Dilagent::

• remove all air from the balloon by inserting a 50ml syringe into the non return valve and sucking the air out;
• sit in a bath of warm water for at least 5 minutes to clean and thoroughly relax the perianal muscles.

The left lateral position (Sims) is recommended for the insertion of the balloon (Fig. 2).

Alternatively, the balloon can be inserted while seated on the bidet.

Fill the syringe with warm water at a temperature of between 40–50 ml (hot water from the bath tap).

Lubricate the balloon completely deflated with the ointment contained in the kit, and very carefully insert it to its full length into the anal canal until the collar is in contact with the anal skin. Pass the tube of the Dilagent up between the thighs and hold the non return valve (see figure 1) in the fingers. Take the syringe, previously filled with 50ml of warm water and insert it into the non return valve. Very slowly start to inflate the balloon with 10 ml until you feel the sensation of heat in the anal canal. Gradually introduce more water until the balloon contains at least 30ml. Keep the Dilagent inserted for 12–15 minutes.

N.B. In the case of an acute anal fissure, where there is acute pain and bleeding, the introduction of 30 ml of warm water could become painful. Therefore it is recommended to introduce only between 10 and 20 ml for the first two or three days.

The maximum quantity of water to be inserted into the balloon is 50ml.

After 12 to 15 minutes deflate the balloon by sucking the water out with the syringe. Take the Dilagent collar and extract it very slowly. Wash the anal region thoroughly with warm water and Sapigen K soap. Dry with a soft cloth avoiding the use of toilet paper.

Wash the Dilagent under warm running water and wash the balloon with the Marsiglia soap. Dry the balloon with a cloth and leave the Dilagent in a dry environment.

NB. The special shape of the Dilagent allows movement and walking around the house. So the person is not obliged to lie in bed or be seated on the bidet.. Nevertheless, it is recommended that he movement is limited to avoid possible injury to oneself or to the Dilagent.

Dilagent Function

The Dilagent is gradually filled with warm water after being carefully inserted into the anal canal. The main feature is ability to control the volume of the balloon as required by the symptoms. The special shape of the balloon guarantees the spread of heat not only in the anal canal (both internal and external sphincters) but also to the puborectalis muscle and to the muscles of the distal tract of the rectal ampulla, all of which are involved in the hypertone. Thanks to the shape of its distal extremity, the balloon is anchored to the pubrectalis muscle thus not moving during movement of the patient (Fig. 3).

The reduction of the sphincteric hypertone allows the reduction of the painful symptoms.

Treatment Schedule

The treatment should be continued for 3-­‐4 weeks. The quantity of water introduced into the balloon should be equal to or more than 25ml. As the painful symptoms reduce during the treatment, the patient must increase the quantity of water into the balloon each time. During the Rectum Puborectalis muscle Dilagent 4 third and fourth week of treatment the quantity of water introduced into the balloon should be 40–50 ml.

During the first week introduce into the balloon the quantity of water necessary to feel a sense of heat in the anal canal using the amount of water according to the symptoms. Bear in mind that a greater introduction of water corresponds to a greater expansion of the balloon that is an essential condition for healing.

The recommended treatment schedule for four weeks is as follows:

• before each treatment sit in a bath of warm water for 5 minutes to thoroughly relax the perianal muscles;
• for the first two weeks use the Dilagent three times a day (morning, afternoon and evening) for 12–15 minutes each time;
• for the next two weeks reduce to two times a day (morning and evening) for 12–15 minutes each time.

Non ci sono controindicazioni ad un uso più prolungato o ad un maggior numero di applicazioni al giorno del Dilagent.

Contraindications

There are no contraindications to the use of the Dilagent.

Undesired effects

During the treatment there may be displayed rectal tenesmus (constant sensation of wanting to go to the toilet), anal itching and a feeling of a wet anus. These symptoms are temporary and will disappear at the end of the Dilagent treatment. In the first weeks, above all in case of acute diseases (anal fissure, acute haemorrhoidal thrombosis), the pain may increase during the treatment time especially during the first days. In such cases, it is recommended to not stop the treatment but to take a painkiller that will reduce the pain and allow the Dilagent treatment to be continued. If the pain should be so intense that it is not possible to continue the therapy, the treatment should be suspended and you should consult your Specialist.

Special precaution

The Dilagent is a medical device and therefore must be used for the treatment for the pathology described above. It is prohibited for any other use.