The purpose of this study is to evaluate the safety and pain management effect of a novel therapy administered into the bladder for cats suffering from non-obstructive feline idiopathic cystitis (FIC), with a focus on clinical and behavioral response. Due to its mode of action this novel therapy is known to delete chronic pain pathways, which are responsible for transmitting pain and propagating the inflammation of the bladder cats with FIC . The study involves a one-time treatment with this novel therapy, administered into the bladder, targeting the nerves responsible for the pain sensation in cats with FIC. The treatment will be administered under general anesthesia. There is a placebo group in this study. Owners will be required to complete a survey evaluating the cystitis symptoms each week for the duration of the study. The study site will train the owners on evaluation techniques. Study visits include the cats’ initial consultation, treatment day (Day 0), and then recheck visits on Days 14 and 28. Other medications for FIC, except for CBD and other cannabinoids, are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study and no changes in regimen are expected in the next 4 weeks. Each study site will need to have a masked Investigator and an unmasked Treatment Administrator.
The study is fully funded for the full study duration (28 days). Funding includes the initial consultation, the study treatment and administration, recheck visits, required bloodwork, required imaging, and management of side effects that are thought to be directly related to participation in the study.
Trained veterinarians at the study sites will evaluate each cat for eligibility. Cats are eligible if they meet the following inclusion criteria:
- The cat has active non-obstructive FIC with a minimum of two episodes of FLUTD within the preceding 6 months and is experiencing refractory clinical signs.
- The cat has signs related to non-obstructive FIC including, but not limited to vocalizing while urinating, inappropriate elimination, dysuria, and / or pollakiuria.
- The cat reaches the minimum clinical symptom scoring requirements, as assessed by the veterinarian.
- Urinalysis results show no presence of aggregate crystals. However, occasional crystals on urinalysis are acceptable.
- Medications commonly used for the treatment of behavioral changes or clinical signs, even if they have been prescribed for another reason (e.g., corticosteroids for a dermatological condition) are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study, and no changes in regimen are expected in the next 4 weeks.
- If the cat is receiving a TRPV1 agonist or antagonist including but not limited to, cannabinoids (e.g., cannabidiol (CBD), anandamide), a 28-day washout period is required.
Cats are not eligible if they meet any of the following exclusion criteria:
- The cat is less than 12 months of age.
- The cat’s body weight is less than 2 kg.
- The cat is unlikely to survive a 30-minute anesthesia or sedation procedure.
- The cat would be unlikely to survive 4-weeks due to health issues other than FIC.
- The cat presents with urolithiasis, bacterial infection, bladder neoplasia or congenital deformity.
- The cat may be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for another reason.
- The cat is participating in another study.
- The cat is pregnant or lactating.
- The cat requires medication or supplements during the course of the study that may interfere with the objective of the study.
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