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Purpose and Brief Explanation of Study:
The purpose of this study is to evaluate the efficacy of a new diet specially formulated to dissolve struvite stones in the bladders of cats. Struvite stones are among the most common types of bladder stones that can form in cats. They can cause irritation and pain and can lead to blood in the urine and possible obstruction of the urethra (the urine outflow tract). Standard treatment is to either remove them surgically or dissolve them by altering the pH and other characteristics of the cat’s urine. This is done through medications or by exclusively feeding a diet that is specially formulated to promote stone dissolution. Most struvite stones can be dissolved in 1 – 3 months with strict dietary compliance.
Objective of the trial:
In the current study we are evaluating a new diet for efficacy in struvite dissolution in cats. We are recruiting cats with evidence of struvite urolithiasis and asking that their owners feed them the dry form test diet exclusively for up to 8 weeks with recheck evaluations every 2 weeks until the stones are dissolved.
What qualifies my cat for enrollment in this in this trial?
All cats with a suspicion of struvite urolithiasis will undergo screening consisting of abdominal radiographs under light sedation, Complete Blood Count, Serum Chemistry analysis, urine collection via cystocentesis for urinalysis and urine culture, body weight assessment and physical examination by the Principle Investigator. If the cat is deemed likely to have struvite stones and is otherwise healthy, the pet may be enrolled in the study.
What does enrolling my cat in this clinical trial involve?
Each cat will be fed the Test Diet exclusively at home. It is a complete and balanced diet and may be fed to other healthy cats in the household as long as there are no additional dietary requirements. No other foods, including supplements, vitamins, or treats may be fed. Fresh water must be available at all times. The owner will be provided with the diet and will be given instruction on how much to feed daily basis using standard guidelines based on the animal’s weight and maintenance calorie needs. The first day of feeding will be named Day 0.
At Days 14, 28, 42, and 56 the owner will bring the cat back to the hospital for the following procedures: Physical examination by the Principle Investigator, abdominal radiography under light sedation, body weight, and urine collection via cystocentesis. All abdominal radiographs will be reviewed for evidence of stone dissolution. If the stone(s) are no longer present at one of the above time points, a Complete Blood Count and Serum Chemistry will be performed. If the stones have not dissolved by Day 56, a cystotomy will be performed and the stones analyzed for mineral content.
All examinations, radiography, blood and urine testing listed above will be paid for by the study. If the cat has stones at the end of 56 days (8 weeks), the study will pay the cost for the cystotomy and stone analysis. The Test Diet will be provided in bagged dry form by the manufacturer at no cost to the client.
Upon completion of the study, the sponsor will provide up to 6 months of the Test Diet without charge. If another diet manufactured by the sponsor is deemed more appropriate by the PI, that diet may be provided in lieu of the Test Diet.
If you believe that your pet may be eligible to enter this study, please have your veterinarian click here to fill out a questionnaire. This must be completed by your veterinarian.