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Elmiron

Pentosan polysulfate (sold under the name Elmiron) was the first --and only-- oral medication approved by the US FDA for the treatment of interstitial cystitis, also known as painful bladder syndrome. Interstitial cystitis patients struggle with symptoms of urinary frequency, urgency, pressure and/or pain, as well as nocturia (frequent urination at night), dyspareunia (painful intercourse), pain and/or discomfort while sitting in a car, while driving and/or travelling. more...

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The origin/cause of IC is unknown though a number of theories are currently under consideration. Urine cultures are typically negative for infection, yet it is not unusual for patients to believe that they have had infections for years rather than IC. Why? Because the symptoms of an infection are nearly identical to the symptoms of IC.

Diagnosis has been greatly simplied in recent years with the development of two new methodologies. The Pelvic Pain Urgency/Frequency (PUF) Patient Survey, created by C. Lowell Parsons, is a short questionnaire that will help doctors identify if pelvic pain could be coming from the bladder. The KCL Test, aka the Potassium Sensitivity Test, uses a mild potassium solution to test the integrity of the bladder wall. Though the latter is not specific for IC, it has been determined to be helpful in the evaluation of the use of compounds, such as pentosan, which are designed to help repair the GAG layer. The previous "gold standard" test for IC was the use of hydrodistention with cystoscopy. Researchers, however, determined that this visual examination of the bladder wall was also not specific for IC and that the test, itself, can contribute to the development of small glomerulations (aka petechial hemorrhages) often found in IC. Thus, a diagnosis of IC is one of exclusion, as well as a review of clinical symptoms.

Pentosan is believed to work by providing a protective coating to the damaged bladder wall. The critical flaw of the medication, however, is its exceptionally poor bioavailability when taken orally. Research presented late in 2005 by Alza Pharmaceuticals (Metabolism of pentosan polysulfate sodium (PPS) in healthy human volunteers. Xenobiotica. 2005 Aug;35(8):775-84.) demonstrates that more than 84% of the medication is excreted, intact, in feces without providing any beneficial effect. Their research found that only 6% was excreted through urine. Thus, it must be taken for several months for most patients to achieve some benefit. More recently, however, Elmiron has been studied as part of a "rescue instillation" which is placed directly in the bladder and can, perhaps, provide better effectiveness. C. Lowell Parsons has presented a research study which shows a 90% effectiveness in reducing the symptoms of IC patients by using this instillation.

Patients who have taken pentosan orally report a variety of side effects, primarily GI complaints such as diarrhea, heartburn, stomach pain. Hair loss, headache, rash, insomnia have also been reported. One concern is the potential for blood thinning with this medication. Some patients have reported that they bruise more easily. In some cases, patients are asked to stop medication before any major surgical procedures to reduce the likelihood of bleeding.

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Diagnosis of exclusion: symptoms should guide interstitial cystitis Tx
From OB/GYN News, 8/1/04 by Miriam E. Tucker

NEW ORLEANS -- Interstitial cystitis is a commonly missed diagnosis, Dr. Joslyn Fisher said at the annual meeting of the American College of Physicians.

As a cause of chronic pelvic pain in women, interstitial cystitis (IC) presents a major clinical conundrum. Because the disease lacks a specific marker, the diagnosis is made when all else--including recurrent urinary tract infections, endometriosis, overactive bladder, fibromyalgia, and prior or current sexual abuse--is ruled out, said Dr. Fisher of Baylor College of Medicine and Ben Taub General Hospital, Houston.

Interstitial cystitis affects about 700,000 people in the United States, but that number may be a vast underestimate, depending on how the condition is defined. In 1988, the National Institute of Diabetes, Digestive, and Kidney Diseases established research criteria for IC: There must be pain, urgency, and frequency, as well as glomerulations (pinpoint bleeding from bladder distension,) or Hunner's ulcer on cystoscopy; in addition, 13 more conditions, including other types of cystitis, must be excluded (J. Urol. 140[1]:203-06, 1988).

The clinical usefulness of the NIDDK criteria is debated. Even urologists are avoiding cystoscopy, which is invasive and not specific or sensitive. Recent data suggest that glomerulations are seen in as many as half of women without IC, whereas Hunner's ulcer occurs in fewer than 10% of women with IC.

Other invasive diagnostic tests are advised only if there is a specific concern. For example, biopsy is recommended to rule out bladder cancer, urodynamics for suspected detrusor instability, and pelvic/vaginal ultrasound to look for fibroids.

A new tool called the Pelvic Pain and Urgency/Frequency (PUF) scale has been shown to predict the likelihood that a woman would test positive on a potassium sensitivity test (PST) performed via cystoscopy, in which instillation of potassium chloride during hydrodistension causes pain in those with IC.

The PUF questionnaire scores a patient from 1 to 35 on questions like "How many times do you go to the bathroom during the day/night?" and "Do you have pelvic or bladder pain?" A score of 15-19 predicts a 76% likelihood of having a positive PST, and a score of 20 or above suggests a 90% probability (Urology 60[4]:573-78, 2002).

The NIDDK is studying the usefulness of urine biomarkers to diagnose IC, which is thought to arise from a combination of factors, including a defect in the protective glycosaminoglycan layer, an allergic reaction/mastocytosis, and neurogenic inflammation. Antiproliferative factor seems the most promising of several markers being studied in the NIDDK's multicenter Interstitial Cystitis Clinical Trials Group/Research Network, she said.

Treatment is based on symptoms. Small studies suggest some benefit from various nonpharmacologic interventions, including avoidance of irritants, such as caffeine, chocolate, and citrus or other acidic foods; pelvic floor rehabilitation (Kegel exercises); acupuncture; and transcutaneous electrical nerve stimulation.

Giving the patient a name for her condition is often enormously helpful, as is social support. The Web site of the Interstitial Cystitis Association (www.ichelp.org) provides helpful information and support.

Pentosan polysulfate (Elmiron) is the only drug approved by the Food and Drug Administration for the treatment of IC. The dosage is 100 mg three times daily. Data from small studies suggest that the heparin-like agent must be taken for at least 3 months to produce any improvement and for 6 or more months for resolution of symptoms. Symptoms return if the drug is discontinued.

Nonrandomized trials suggest that some patients may benefit from antihistamines--hydroxyzine is the most widely studied--because of IC's characteristic mast cell infiltration. Antihistamines might be helpful in patients who have IC and other allergic symptoms, she said.

BY MIRIAM E. TUCKER

Senior Writer

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