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What is Interstitial Cystitis?
Interstitial cystitis (IC), also known as painful bladder syndrome, is a chronic, idiopathic condition of the bladder characterized by pelvic pain as well as excessive urinary urgency and frequency. This condition is often debilitating, interfering with daily activities, social functioning, and sexual activity. The disease afflicts upwards of 700,000 women, who comprise roughly 90% of the affected population.
Pelvic pain is the most prominent symptom of interstitial cystitis. It is often relieved upon urination but returns as the bladder fills. However, urinary urgency is not usually relieved with urination. Urinary frequency averages 16 times per day but can be as high as 60 times per day in some patients. This frequency can contribute to nocturia (urination at night), but usually does not include incontinence. Another symptom experienced by many patients is pain with sexual intercourse.
The clinical course of this disease usually involves flare-ups followed by periods of remission. In women, symptoms may worsen during ovulation or during the premenstrual period.
Symptoms may be exacerbated by acidic foods such as coffee, carbonated beverages, other caffeinated products, alcohol, citrus fruits, spicy foods, and tomatoes. Some patients are also sensitive to foods containing high levels of arylalkylamines (i.e. tryptophan, tyrosine, tyramine, phenylalanine) such as beer, cheese, bananas, chocolate, wine, and yogurt.
This condition is highly detrimental to one’s quality of life and may often be misdiagnosed or go undiagnosed. It is important to be aware of the symptoms surrounding this syndrome and to educate oneself about options in therapy. Contact Buderer Drug Co. if you have questions or would like additional information about IC.
Common Characteristics Of Interstitial Cystitis
Presence of pelvic, suprapubic, perineal or bladder pain
Presence of urinary urgency or frequency
Pain with intercourse
Bladder capacity of < 350 mL
Negative urine culture
90% of affected patients have non-ulcerous IC, whereas 10% present with the more serious, ulcerous form of IC in which Hunner’s ulcers are found upon cytoscopic examination.
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What Causes Interstitial Cystitis?
Symptoms may present similarly to those of urinary tract infection, but this condition is not infectious in nature - urine cultures are negative for bacteria. One theory postulates that the chronic bladder inflammation and irritation is caused by a defect in the protective mucous layer of the bladder. This inner lining of the bladder has lower rates of glycosaminoglycan (GAG) excretion in patients with interstitial cystitis. Glycosaminoglycan protects the bladder from damage by maintaining a stable layer of water and by preventing invasion by bacteria and irritation from substances in the urine. In interstitial cystitis, the flawed defensive layer allows irritating substances to seep through the urothelium and lead to injury. The body responds to this injury by releasing inflammatory mediators and histamine, resulting in the symptoms associated with the disease.
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GABA-IC™ - a new and novel treatment for interstitial cystitis
Ongoing research in Interstitial Cystitis has led to the development of a highly specialized, compounded prescription used to treat this insidious condition. GABA-IC™ was developed by Clinical Apothecaries in Medina, OH, and has been licensed to Buderer Drug Co. The preparation is comprised of four different medications in a special aqueous vehicle to facilitate drug contact with the bladder wall. GABA-IC™ is instilled directly into the bladder in the physician’s office seven times over a two week period. Initial findings are showing either total remission or a significant and profound reduction in the symptoms of IC. GABA-IC™ must be compounded by our pharmacy during the week prior to your scheduled visits. The individual medications in GABA-IC™ are FDA approved but their use in this combination and dosage form are considered “off label”. For this reason and because of initial successes, Clinical Apothecaries has a US patent pending on this new and novel product. Since October 2004, only a small number of patients have needed a single “booster” installation to get them through an exacerbation of their IC. This indicates that the vast majority of people who have received GABA-IC™ have achieved complete remission (no symptoms whatsoever). GABA-IC™ can only be purchased through Buderer Drug Co. or Clinical Apothecaries with a valid prescription from a licensed prescriber. The formulation will be sent directly to the physician’s office to make it as convenient as possible for the person undergoing this unique treatment.
Legal Statement: These statements have not been evaluated by the US Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any illness. This statement must appear until the formal process of drug approval in the US is complete.
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How does GABA-IC™ work?
Interstitial cystitis is a chronic, painful and often debilitating disease, whose etiology and pathophysiology is largely unknown. It is often described in the medical literature as a neuro-immuno-endocrine disorder. This is a scientific way of saying that the nervous, immune and hormonal systems of the body may all be involved in IC. GABA-IC™ is a highly specialized, compounded pharmaceutical that contains four different medications in a unique delivery vehicle and system. The individual pharmaceuticals in GABA-IC™ work synergistically to restore and repair each of the different issues associated with IC. The first ingredient calms and quiets the nerves in the bladder, leading to a reduction in pain and urgency. The second ingredient relieves the irritation and inflammation associated with IC. The next ingredient eliminates histamine release which contributes to the irritation and pain. The final component may increase nitric oxide which indirectly helps to repair the bladder wall.
Because the majority of people with IC are women, there may also be a bio-identical hormone replacement therapy (BHRT) component to the treatment regimen. This would correct any underlying hormone imbalance. Saliva test kits are available at Buderer Drug Co. to test your hormone balance.
The actual mechanisms of action of GABA-IC™ is still unproven. However, based on the proven mechanisms of action and FDA approval of its individual components, this is its hypothesized mechanisms of action.
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How is GABA-IC™ prescribed?
We can’t make ordering GABA-IC™ any easier. The physician or other licensed prescriber just needs to fax, call or write a prescription in the usual fashion to Buderer Drug Co. The prescription should state: “GABA-IC™ per Protocol”. Preprinted prescription blanks may also be ordered for those offices prescribing GABA-IC™ on a regular basis. Once GABA-IC™ has been ordered, Buderer Drug Co. will ship seven, 30mL syringes containing the GABA-IC™, latex free catheters and all the necessary paperwork to the prescriber’s office. The cost of GABA-IC™ is $600.00 for the complete regimen and can be billed either to the prescriber’s office or the patient may pay up front and submit for reimbursement themselves.
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Insurance billing
Because the ingredients in GABA-IC™ are FDA approved it may be billed like any other compounded prescription. Buderer Drug Co. will provide both the prescriber’s office and the patient with the necessary information to receive reimbursement from most insurance carriers. An invoice with the corresponding NDC numbers and all other necessary data will accompany the pharmacy invoice. Offices that are interested in providing GABA-IC™ as a service to their IC patients should call Buderer Drug Co. to inquire about the ordering and billing process. Our trained staff will be more than happy to assist you.
For Medical Billing:
The HCPCS Code is J3490
E&M Code for Bladder
installation: 51700
ICD-9 Codes:
Interstitial Cystitis = 595.1
Urinary urgency = 788
Incontinence = 788.31
Hematuria = 599.7
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Information for prescribers
GABA-IC™ is instilled directly into the bladder in the physician’s office seven times over a two week period. It’s typically administered Monday through Friday of the first week then Tuesday and Thursday of the following week. The complete procedure takes only a few moments and can typically be performed by other trained staff members. Some patients who can “self-catheterize” may be able to administer the GABA-IC™ to themselves in their own homes.
A drug monograph and a written copy of the complete protocol will accompany every shipment of GABA-IC™.
Some offices have also asked about home health care agencies providing this service. At this point we have no experience with this situation but we will relay any information we receive about using these types of services.
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How is interstitial cystitis treated?
Since there is currently no cure for interstitial cystitis, the goal of therapy is to alleviate symptoms. Most patients with interstitial cystitis are able to identify foods and other factors that exacerbate their symptoms. Lifestyle modifications, such as dietary adjustment to avoid aggravating foods, are beneficial and recommended. In addition to medical therapy, patients also benefit from emotional and psychological support. GABA-IC™ may become the new standard therapy if data continues to confirm its effectiveness in the treatment of IC.
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Traditional treatment strategies for Interstitial Cystitis
The only FDA-approved oral medication for treatment of interstitial cystitis is Elmiron® (pentosan polysulfate sodium -PPS), which has become the foundation for treatment of this condition. It has been shown to be effective in only 30% of cases. PPS is a heparin-like product that is structurally similar to GAG and may help repair and restore the integrity of the damaged mucous layer. Standard dosing is 100 mg three times daily one hour before or two hours after meals. The approximate cost of Elmiron® to the patient is over $3,000.00 per year. Elmiron® is a registered trademark of IVAX Research, Inc., under license to Ortho-McNeil Pharmaceutical, Inc.
Another FDA approved therapy is intravesical instillation of dimethyl sulfoxide (DMSO). DMSO helps relieve pain and inflammation when administered into the bladder. Histamine released by mast cells also contributes to interstitial cystitis and DMSO may stabilize these cells. It also exhibits muscle relaxant properties that can help with symptoms of urgency and frequency. Typical dosing is instillation of 50mL DMSO (50% aqueous solution) directly into the bladder via a catheter, where it remains for 15 minutes. This is repeated every 2 weeks until symptomatic relief is achieved (usually 4-8 treatments). Maintenance dosing is usually every 1 or 2 months as needed. Administration of DMSO is usually done in a clinician’s office but some patients may learn to self-catheterize at home.
There are also many other medications used in the treatment of interstitial cystitis, although not specifically FDA approved for this indication. Low dose tricyclic antidepressants such as amitriptyline, doxepin, and imipramine are beneficial in relieving pain and in decreasing urinary symptoms. Antihistamines such as hydroxyzine can help diminish the effects of histamine on the cascade of chemical mediators released upon injury. Traditional analgesics may help relieve mild discomfort, but they may also lead to the release of histamine, contributing to flare ups. Other medications that may be considered include neuroleptic medications such as gabapentin, urinary analgesics such as phenazopyridine, anticholinergics such as oxybutynin chloride, skeletal muscle relaxants such as cyclobenzaprine, and calcium channel blockers such as nifedipine. Intravesical instillation of heparin may also be considered for its anti-inflammatory effects, protective effects, and ability to inhibit scarring.
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Natural Supplements
In addition to conventional medications for interstitial cystitis, there are various natural products available that may help control symptoms. Methylsulfonylmethane (MSM), which is also known as dimethyl sulfone (DMSO2), has been used in practice as an alternative to DMSO. It can be administered intravesicularly, orally, topically, or intravenously. Often, a combination of these routes is used. MSM does not have the same garlicky odor as DMSO so it may be better tolerated, but it may also take longer for patients to experience improved symptoms. Another approach targets nitric oxide deficit observed in interstitial cystitis patients and the symptom improvement associated with elevation of nitric oxide levels. Arginine is a natural precursor of nitric oxide and may be considered for treatment. Results from small trials have showed mixed results, but the trials may have been too small to detect statistical significance between different outcomes. Plant sterols can decrease inflammation through modulation of the immune response. Quercetin is a bioflavonoid found in red wine, onions, and green tea that reduces mast cell release of histamine and may relieve interstitial cystitis symptoms. Another promising supplement that is being studied is melatonin, which may stabilize and protect the urothelium - safety and efficacy must be established.
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References:
Elmiron® package insert provided by U.S. FDA 633-20-506-1
Dell J, Butrick C. Multimodal therapy for painful bladder syndrome/interstitial cystitis. J Reprod Med. 2006;51(3):253-260.
Lexi-Comp Online, Lexi-Drugs Online, Lexi-Comp Inc. Hudson, OH. Available at: http://crlonline.com/crlsql/servlet/crlonline. Accessed Feb 14, 2007.
Marshall K. Interstitial cystitis: understanding the syndrome. Altern Med Rev. 2003;8(4):426-437.
Metts J. Interstitial cystitis: urgency and frequency syndrome. Am Fam Physician. 2001;64(7):1199-1206.
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Additional Resources
Interstitial Cystitis Association
110 North Washington Street, Suite 340
Rockville, MD 20850
(800) HELP-ICA
(800-435-7422)
http://www.ichelp.org
National Kidney Foundation
30 E. 33rd Street
New York, NY 10016
(800) 622-9010
http://www.kidney.org
Clinical Apothecaries
4087 Medina Rd., Suite 200
Medina, OH 44256
877-231-7889
pharmacist@cairx.com
Buderer Drug Co.
26611 N. Dixie Hwy.
Suite 119
Perrysburg, OH 43551
419-873-2800
info@budererdrug.com
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These statements have not been evaluated
by the Food and Drug Administration. These preparations
are not intended to diagnose, treat, cure, or prevent
any disease. |
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