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Interstitial Cystitis Study
Do you find yourself in the restroom frequently urinating with pelvic pain and pressure? Does it seem to depend on what you eat as much as what you drink? You may have Interstitial Cystitis, a painful bladder syndrome.
We are conducting two studies of new medications for the treatment of Interstitial Cystitis. Please see below for more information. To view a detailed brochure for one of our IC studies, please click here.
If you are interested, please call our research nurses at: (616) 588-1130 or sign up for more information.
1. Will the insertion of the LiRIS device in my bladder increase the frequency of my need to urinate? Our experience to date with LiRIS has shown that some women had a decrease in urinary frequency, others had no change, and there is a possibility that a woman could have an increase in frequency.
2. Will I be able to go about my everyday activities? (Exercise, running, yoga, etc) This is up to you and your physician based on your symptoms, but restrictions in everyday activities are not required. Everyday activities are not expected to be impacted in a negative way as a result of participating in this study.
3. What is the recovery period I should expect after the LiRIS insertion procedure is completed? The recovery period is similar to a cystoscopy procedure is 24-48 hours. The placement of LiRIS is not expected to change the recovery typically seen after a cystoscopy.
4. Is there a chance the LiRIS device could be expelled while going to the bathroom? If so, will it hurt? While this is an unlikely event, there is a possibility. When this unlikely event has happened, it has not been a painful experience for the patient.
5. What are the risks of the insertion and removal of the LiRIS device? The risks are similar to the risks of a cystoscopy procedure.
6. Has the LiRIS device been clinically tested in human subjects before? LiRIS 200mg and LiRIS 650mg have been clinically tested in human subjects and was generally well tolerated. LiRIS 400mg has not been clinically tested in human subjects as of yet but is very similar in size and shape to the two dosage strengths that have already been tested.
7. Why was lidocaine chosen to treat bladder pain? Lidocaine has been documented to provide relief for some IC patients when used in a bladder instillation.
8. Is 400mg of lidocaine does strong enough to treat bladder pain? Patient who have received the LiRIS 200mg or LiRIS 650mg have reported pain relief, this supports the hypothesis that the LiRIS 400mg will perform similarly. This is one of the main objectives of the research study.
9. How does the 400mg dose of lidocaine compare to the dosage normally received for something like a dental procedure (i.e. the numbing procedure for filling a tooth or root canal)? The dose of lidocaine given with a dental procedure is given locally and over a short period of time to induce numbness. The lidocaine delivered by the LiRIS device is slowly released into the bladder (a larger area) and over many days. The dose chosen is expected to provide local analgesia (pain relief), but not actually numb that bladder wall. Patients who have received the LiRIS 200mg or LiRIS 650mg have not experienced bladder incontinence or urine retention.
10. Is lidocaine well tolerated in the bladder? Based on published data from intravesical lidocaine instillations, lidocaine is considered well tolerated in the bladder at the concentrations being studied.
11. How would a person know if they are allergic to lidocaine? The symptoms of an allergic reaction to lidocaine could include local effects like inflammation, discomfort, sensitivity, burning, itchiness of the skin, or systemic effects like swelling, rash, hives, and shortness of breath. Most people have had lidocaine or similar anesthetics used during dental procedures. If you've had any of these reactions with dental work or you've been told by your dentist or your doctor not to receive Novocaine or lidocaine during these procedures or other procedures requiring anesthesia, then you shouldn't participate in this study.
12. Should a potential participant be tested for lidocaine allergy before enrolling in the trial? Lidocaine allergies are very rare and when seen they usually happen when lidocaine is injected into the spinal cord as a nerve analgesic. This doesn't mean a person who receives the LiRIS device might not have a reaction.
13. How much discomfort and/or pain is associated with the insertion and then removal of the LiRIS device? The discomfort is the same as seen with a cystoscopic procedure. A cystoscopy is a procedure that is carried out using a specialized endoscopic instrument called a cystoscope. The cystoscope is a long lighted tube that has a small camera at the end, allowing a view of the inside of your bladder and urethra. Cystoscopy is sometimes used in the diagnosis of IC.
14. What is the risk of infection with the insertion of the LiRIS device? The risk of urinary tract infection is expected to be similar to the risk associated with cystoscopic procedures for this reason, the urologists participating in this trial may provide a single dose or a short course of antibiotics at time of insertion and removal. This is similar to their current practice of giving antibiotics to patients when they have a cystoscopic procedure.
15. is it safe to have sexual intercourse while the LiRIS device is implanted? Previous studies conducted with LiRIS have not required abstinence in sexually active subjects. To date, no issues with sexual intercourse while LiRIS is in the bladder have been reported.
16. How does the size of LiRIS device compare to the size of an IUD (intrauterine device)? LiRIS is similar in size to an IUD, about the length and width of 2 quarters side by side.
17. Does LiRIS cause any loss of bladder control? There has been no recorded evidence of incontinence to date in the approximately 20 patients who have participated in previous clinical studies.
18. If the patient is pleased with their results while receiving the 400mg dosage of LiRIS, how often would it need to be inserted and removed? The LiRIS device is intended to be used as needed. Additional clinical studies will be conducted to understand how often LiRIS may be inserted and removed to effectively treat patients who have IC over a longer period of time.
19. Is there any lasting effect of the lidocaine after the LiRIS device is removed? If so, what is the average amount of time? In the approximately 20 patients who've received LiRIS so far, some patients have reported positive effects on their symptoms continuing after the LiRIS device is removed. The duration of this effect will be evaluated in this study.