Description
Retrograde colonic irrigation system.
Transanal irrigation with Peristeen Plus has the aim of facilitating the evacuation of the contents of the lower colon and the descending colon through the use of a rectal catheter with an inflatable balloon.
The product is indicated for patients suffering from faecal incontinence, chronic constipation and/or time consuming bowel management procedures.
The product is indicated for adults (of both sexes) and children over 3 years of age. The Peristeen catheter pack consists of ten regular rectal catheters that self-lubricate when in contact with water.
The rectal catheter is disposable.
The rectal balloon catheter is available in two sizes:
- the small catheter, labeled with a smiley face, is normally used for children;
- the regular catheter is normally used for adults.
For hygienic reasons, the Peristeen Plus Transanal Irrigation System is single-patient use.
Reuse of the pre-lubricated rectal catheter is not recommended due to the risk of cross-contamination.
Reprocessing, washing, disinfection and/or re-sterilization could compromise the characteristics of the product, resulting in an additional risk of physical harm or infection for the patient.
Coloplast assumes no responsibility for injury or loss that may occur if the product is used in a manner not in accordance with Coloplast's current recommendations.
Transanal irrigation with Peristeen Plus should not be performed in the following situations, as mechanical obstruction or tissue weakening of the colon caused by any of the following factors increases the risk of bowel perforation, trauma or bleeding:
- known anal or colorectal stenosis;
- colorectal cancer (active/relapsing);
- within 3 months of having anal or colorectal surgery;
- within 4 weeks of endoscopic polypectomy surgery;
- ischemic colitis;
- acute inflammatory bowel disease;
- acute diverticulitis.

Warnings
- Transanal irrigation with Peristeen Plus is not recommended if you are pregnant or planning to be pregnant as the product has not been evaluated in this patient population.
- It is essential for patient safety to consult a doctor/healthcare professional experienced in the use of transanal irrigation with Peristeen Plus before performing the irrigation procedure.
- Before using this product you should receive thorough instructions from a healthcare professional, who should also supervise the first irrigation.
- The transanal irrigation procedure must always be performed with caution.
- Make sure that the size of the catheter (Regular or Small) indicated on the package corresponds to those recommended by your healthcare professional. The insertion of the balloon catheter should not be forced. Bowel perforation occurs very rarely with transanal irrigation, but is a serious and life-threatening complication that requires immediate hospitalization and often surgery. Seek immediate medical attention if any of the following occurs during or after the Peristeen Plus transanal irrigation procedure:
- severe or prolonged abdominal pain or back pain, especially if associated with fever;
- severe or prolonged anal bleeding.
- Reuse and/or washing or disinfection of the balloon catheter is not recommended as it is pre-lubricated, these operations could compromise the characteristics of the product, causing an additional risk.