- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Incurin is a veterinary medicine used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically). Incurin contains the active substance estriol.
The medicine can only be obtained with a prescription.
Incurin is available as tablets. As the sensitivity of incontinent dogs to estriol is variable, the dose of Incurin is determined on an individual basis.
For more information about using Incurin, see the package leaflet or contact your veterinarian or pharmacist.
Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
The term urinary incontinence is used to describe the condition of involuntary leakage of urine. It is known to occur in bitches, with the incidence being highest after ovariectomy. This condition is accompanied with a decrease of the endogenous oestrogen production. Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion. Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.
Incurin has been studied in bitches in three large field trials. During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
The studies also established that there is no apparent relationship between the dosage and the body weight of the dog – therefore the dosing has to be decided on an individual basis.
The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term. The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
Side effects typical to oestrogens such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog. The incidence is about 5-9 %. These effects are reversible after lowering the dose.
In rare cases vaginal bleeding occurred. In very rare cases development of alopecia (loss of hair) has also been observed.
Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.
For the full list of side effects and restrictions of Incurin, see the package leaflet.
No special precautions are necessary when administering Incurin.
The European Medicines Agency decided that Incurin’s benefits are greater than its risks and it can be authorised for use in the EU.
Incurin received a marketing authorisation valid throughout the EU on 24 March 2000.
Product information
Product details
- Name of medicine
- Incurin
- Active substance
- estriol
- International non-proprietary name (INN) or common name
- Estriol
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QG03CA04
Pharmacotherapeutic group
Sex hormones and modulators of the genital systemTherapeutic indication
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.